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  5. Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs - 676367 - 04/17/2024
  1. Warning Letters

WARNING LETTER

Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs MARCS-CMS 676367 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Charles E. Balentine
Recipient Title
CEO
Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs

315 Deaderick Street Suite 1550
Nashville, TN 37238-3003
United States

Issuing Office:
Center for Devices and Radiological Health

United States

WARNING LETTER
CMS # 676367

April 17, 2024

Dear Mr. Balentine:

During an inspection of your firm, Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs, located at 315 Deaderick Street, Suite 1550, Nashville, TN 37238-3003 on October 27, 2023, November 1, 2023, and November 3, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm markets and distributes the Second Generation FIT Fecal Immunochemical Test. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Misbranded and/or Unapproved Device Violations

Our inspection revealed that your firm sells the Second Generation FIT Fecal Immunochemical Test. The product insert for the Second Generation FIT Fecal Immunochemical Test states under the section titled Intended Use:

“This test is recommended for use in…screening for colorectal cancer or gastrointestinal bleeding.”

A product brochure for your device obtained during the inspection includes additional statements as examples that your product is intended for use in colorectal cancer screening:

  • “For the average risk person (45 and older) Second Generation FIT is the smart choice for colon cancer screening.”
  • “Second Generation FIT is a reliable, potentially life-saving test that can give you the information you need to take action, or the piece [sic] of mind to know that you are up to date with screening and no further action is needed for a calendar year.”
  • “This guide was designed to let you make an informed decision about colon cancer screening. The information in this booklet will help you decide if the Second Generation FIT® test is right for you.”
  • “Continue reading to see how the Second Generation FIT® test is changing the landscape of colon cancer screening for all average risk people.”

Additionally, your firm’s website includes the following statements and information demonstrating that your device is intended for use in the screening of colon cancer. During the inspection, you stated that these statements would be removed, however, as of the date of this letter the following statements appear on your firm’s website as examples that your device is intended for use in colorectal cancer screening:

  • “Second Generation FIT® Fecal Immunochemical Test is a proven and recommended colon cancer screening tool used by doctors and hospitals nationwide.” [https://www.pblabs.com/products/second-generation-fit-fecal-immunochemical-test-2-pack]
  • “With a negative result, you are considered screened for colon cancer and your next step is to test again in a year, while a positive result should be followed up with a colonoscopy.” [https://www.pblabs.com/products/second-generation-fit-fecal-immunochemical-test-2-pack]
  • “Second Generation FIT® is the go-to colon cancer screening test for hospitals, health fairs and non-profits who are screening large numbers of people.” [https://www.pblabs.com/pages/colon-cancer-screening-with-fit]
  • “A negative result, or one line at the control (C) region, is the optimal outcome for the Second Generation FIT® test. You are considered screening for colon cancer and your next step is to re-screen in a year. Pinnacle BioLabs will even send you a reminder and 10% off twelve months after you order.” [https://www.pblabs.com/pages/screening-with-second-generation-fit]
  • “Their test has been the bestselling colon cancer screening test in the United States for 6 consecutive years. Pro’s of the Second Generation FIT test include its OTC designation with the US Food and Drug Administration…” [https://www.pblabs.com]

During the inspection you stated that your intent is to be a private label distributor of the previously-cleared (b)(4) Fecal Occult Blood (FOB) (b)(4). The Second Generation FIT Fecal Occult Blood (FOB) Self-Test was originally cleared as (b)(4) Fecal Occult Blood (FOB) (b)(4) for the detection of fecal occult blood, with the following intended use:

The (b)(4) Fecal Occult Blood (FOB) (b)(4) is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as an over-the-counter product for home use. Measurement of FOB is useful as an aid to detect blood in stool as found in a number of gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. It is intended for over-the-counter use.

Based on information obtained during the inspection and statements on your firm’s website, you are marketing and distributing the previously-cleared (b)(4) Fecal Occult Blood (FOB) (b)(4) for a new intended use that is different from the cleared use in (b)(4). You have modified the previously-cleared device and manufactured a new device, the Second Generation FIT Fecal Occult Blood (FOB) Self-Test, with a new intended use. For example, you have repackaged and relabeled the previously-cleared device1 and you have replaced the manufacturer’s package insert with your own labeling with a statement that your device is intended for use in colorectal screening. Whereas the previously-cleared (b)(4), which is classified under 21 CFR 864.6550, was cleared as “as an aid to detect blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.”2 These are significant changes to the previously-cleared device’s intended use and your device is not considered the same device as the (b)(4) Fecal Occult Blood (FOB) (b)(4). Devices classified under 21 CFR 864.6550 are intended to detect occult blood in feces. They are not intended for colorectal cancer screening. Similar devices intended for colorectal cancer (CRC) screening are class III devices that require premarket approval.3 CRC screening tests are used in a broad screening population with average risk for colorectal cancer. Your device has not been evaluated for use in a colorectal cancer screening population. The sensitivity and specificity of your device for colorectal cancer screening have not been evaluated. Generally, such an evaluation would be determined using a prospective clinical study in which colonoscopy is the reference method. However, your device website states that your test’s clinical performance is 98% analytical sensitivity and 96% analytical specificity which appears to be taken from the 510(k) clearance and is not reflective of your test’s clinical performance in screening for colorectal cancer. There are significant differences in the risks from false results generated from the previously-cleared class II device (b)(4) and a device intended for colorectal cancer screening. Notably, false positive results obtained from a colon cancer screening test may lead to unnecessary colonoscopies and may expose patients to adverse events such as bleeding, infection, and bowel perforation. False negative results obtained from a colon cancer screening test may lead to missed or delayed diagnosis of colorectal cancer. Patients with missed colorectal cancer will present at a later stage with more advanced disease and poorer outcome. As previously discussed, this previously-cleared device was not intended for colon cancer screening. That performance data indicates the performance of the previously-cleared device to detect the presence of fecal occult blood. It does not give the clinical performance of your test’s ability to screen for colorectal cancer. FDA is not aware of any data demonstrating the safety and effectiveness of your device when intended for use in colorectal cancer screening. If you have data demonstrating these performance characteristics, please provide that information to the agency in a new premarket submission.

Therefore our inspection and review of your firm’s website has revealed that the Second Generation FIT Fecal Immunochemical Test is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Quality Systems Violations

This inspection also revealed that this device is adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. As previously discussed, FDA has determined that your firm is manufacturing the previously-cleared (b)(4) Fecal Occult Blood (FOB) (b)(4). Under 21 CFR 820.3(o), the definition of the term “manufacturer” includes those who perform the function of relabeling or repackaging. As an entity engaged in the manufacturing of a finished device as evidenced by your firms’ relabeling and offering for sale of these devices for a new intended use, your firm is required to conform with the Quality System regulation under 21 CFR part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm has not established and does not maintain complaint handling procedures, and records of complaints received do not include an evaluation for MDR reporting to FDA. During the inspection you confirmed that your firm does not have an established procedure for receiving, reviewing, and evaluating complaints by a formally designated unit complaint and committed to correcting this, however, FDA has not received any response from your firm as of the date of this letter. In response to this Warning Letter, you should provide documentation of your complaint record procedure and any associated evidence of the corrective actions, such as retrospective review of adverse events to determine MDR reportability.

2. Failure to establish procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, your firm has not established and does not maintain CAPA procedures for the initiation and implementation of corrective and preventive action, as required. In response to this Warning Letter, you should provide documentation of your CAPA procedures and details/strategy for initiating CAPAs for customer complaints.

3. Failure to establish and maintain adequate design control procedures to control the design of the device in order to ensure that specified requirements are met, as required by 21 CFR 820.30(a). Specifically, your firm has not established and does not maintain design control procedures, to ensure the intended use of colorectal cancer screening for your Second Generation FIT Fecal Immunochemical Test, as labeled, have been validated. Please refer to the “Misbranded and/or Unapproved Device Violation” section above and provide the testing information to support the new intended use as part of a new premarket submission.

Medical Device Reporting Violations:

Our inspection also revealed that your firm’s Second Generation FIT® Fecal Immunochemical Test is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Specifically, during the inspection, you affirmed to the investigator your firm has not established MDR procedures. During the inspection you committed to correcting this, however, FDA has not received any response from your firm.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Melissa Michurski, Director of Compliance Branch, at oradevices2firmresponse@fda.hhs.gov. Refer to CMS # 676367 when replying. If you have any questions about the contents of this letter, please contact Salvatore Randazzo, Compliance Officer, at 407-475-4712 or salvatore.randazzo@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Blake Bevill
Program Division Director
Office of Medical Device and Radiological Health
Division 2/Central

/S/

Courtney Lias, Ph.D.
Acting Director OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

cc: Megan Peters, Co-Owner, Pinnacle Labs of TN, LLC dba Pinnacle BioLabs,
315 Deaderick St., Suite 1550, Nashville, TN 37238-3003

__________________

1 Under 21 CFR 807.3(d), the definition of the term “manufacture” includes the activity of “[r]epackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.”

2 https://www.accessdata.fda.gov/cdrh_docs/pdf7/K070660.pdf

3 See e.g., https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130017.

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