CLIA Waiver by Application Decision Summaries
Under the Clinical Laboratory Improvement Amendments (CLIA), the FDA categorizes in vitro diagnostic (IVD) tests by their degree of complexity: waived, moderate complexity, and high complexity.
Tests that are waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use or for over-the-counter use, are automatically categorized as waived following clearance or approval. Otherwise, following clearance or approval, tests may be categorized either as moderate or high complexity according to the CLIA categorization criteria listed in 42 CFR 493.17.
A manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to FDA. In a CW, the manufacturer provides evidence to FDA that a test meets the CLIA statutory criteria for waiver, 42 U.S.C. § 263a(d)(3).
Since 2017, the FDA has released decision summaries for test systems for which CLIA Waiver by Application (CW) has been approved. Each CW decision summary contains a review of the data submitted by an applicant to support the determination that a test system meets CLIA statutory criteria for waiver, and FDA's justification in approving the CW application. CW decision summaries allow the public to learn how the FDA reviewed an applicant's data to make a CW approval determination and provide information that is useful for manufacturers preparing future CW submissions. For example, CW decision summaries allow manufacturers to see what types of flex studies and clinical studies other applicants conducted so that they may conduct similar studies.
CW decision summaries are posted below as they become available. For questions or comments about CW decision summaries, please contact CLIA@fda.hhs.gov.
| Test System Name | Document Number | FDA Review Decision Summary | Effective Date (MM/DD/YYYY) |
|---|---|---|---|
| Healgen Scientific, LLC, Healgen Rapid COVID-19 Antigen Test | CW240016 | Decision Summary | 11/12/2024 |
| ACON Laboratories, Mission U120 Touch Urine Analyzer for use with Mission Urinalysis Reagent Strips | CW240008 | Decision Summary | 08/29/2024 |
| InBios SCoV-2 Ag Detect Rapid Test | CW230020 | Decision Summary | 08/23/2024 |
| Nano-Ditech Corporation, Nano-Check RSV Test | CW240005 | Decision Summary | 07/30/2024 |
| Cepheid GeneXpert Xpress System {Xpert HCV} | CW240017 | Decision Summary | 06/27/2024 |
| Nano-Ditech Corporation, Nano-Check COVID-19 Antigen Test | CW240009 | Decision Summary | 06/24/2024 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | CW240014 | Decision Summary | 06/24/2024 |
| Kenota 1 Total IgE for use on the Kenota 1 instrument | CW230008 | Decision Summary | 05/31/2024 |
| ACON Laboratories, Mission U120 Touch Urine Test System | CW240007 | Decision Summary | 05/23/2024 |
| BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | CW230018 | Decision Summary | 03/26/2024 |
| Nova Biomedical Corporation, StatStrip Glucose Hospital Meter System | CW230017 | Decision Summary | 02/23/2024 |
| Trukera Medical ScoutPro Osmolarity System | CW230022 | Decision Summary | 01/09/2024 |
| Cepheid GeneXpert Xpress System {Xpert Xpress MVP} | CW230013 | Decision Summary | 10/19/2023 |
| Universal Biosensor Xprecia Prime Coagulation System | CW230004 | Decision Summary | 03/15/2024 |
| Abbott Diagnostics Afinion HbA1c | CW210007 | Decision Summary | 09/27/2023 |
| Quidel Sofia 2 SARS Antigen+ FIA | CW230010 | Decision Summary | 09/20/2023 |
| Alere Cholestech LDX System | CW220017 | Decision Summary | 09/20/2023 |
| Abbott ID NOW COVID-19 2.0 | CW220006 | Decision Summary | 08/10/2023 |
| Nova Allegro HbA1c Assay for use on the Nova Allegro Analyzer | CW220003 | Decision Summary | 11/22/2024 |
| cobas pulse blood glucose monitoring system | CW220002 | Decision Summary | 04/26/2024 |
| cobas SARS-CoV-2 Nucleic acid for use on cobas Liat System | CW220015 | Decision Summary | 12/04/2023 |
| cobas SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas Liat System | CW220014 | Decision Summary | 07/27/2023 |
| BIOFIRE SPOTFIRE Respiratory Panel Mini | CW230007 | Decision Summary | 05/05/2023 |
| Visby Medical Sexual Health Test (For use with self-collected vaginal swabs) | CW220001 | Decision Summary | 03/07/2023 |
| Chembio Diagnostics Systems, DPP HIV-Syphilis System | CW210001 | Decision Summary | 02/23/2023 |
| BIOFIRE Diagnostics, BIOFIRE SPOTFIRE Respiratory (R) Panel | CW210006 | Decision Summary | 02/03/2023 |
| Sysmex XW-100 | CW210002 | Decision Summary | 11/08/2022 |
| ARKRAY USA, Assure Titanium Blood Glucose Monitoring System | CW200005 | Decision Summary | 05/23/2022 |
| Piccolo Potassium Test System | CW200007 | Decision Summary | 10/20/2021 |
| Visby Medical Sexual Health Click Test (For use with self-collected vaginal swabs) | CW200003 | Decision Summary | 08/26/2021 |
| binx io CT/NG Assay and binx io System | CW200012 | Decision Summary | 03/30/2021 |
| Mesa Biotech Accula {Accula Strep A Test} | CW200009 | Decision Summary | 11/09/2020 |
| Uritek TC-201 Urine Chemistry Test System | CW190011 | Decision Summary | 09/23/2021 |
| Cepheid GeneXpert Xpress System {Xpert Xpress Strep A} (GeneXpert Xpress IV hub configuration) | CW190007 | Decision Summary | 10/18/2019 |
| Cepheid GeneXpert Xpress System {Xpert Xpress Flu/RSV Assay} (GeneXpert Xpress IV hub configuration), Cepheid GeneXpert Xpress System {Xpert Xpress Flu Assay} (GeneXpert Xpress IV hub configuration) | CW190006 | Decision Summary | 09/30/2019 |
| Sekisui Acucy System {Acucy Influenza A&B Test} (For use with direct nasal and nasopharyngeal swab specimens) | CW180008 | Decision Summary | 12/17/2018 |
| Nova Biomedical Corporation StatStrip Xpress Glucose Hospital Meter System | CW180012 | Decision Summary | 12/13/2018 |
| Nova Biomedical Corporation StatStrip Xpress 2 Glucose Hospital Meter System | CW180011 | Decision Summary | 12/13/2018 |
| Mesa Biotech Accula {Accula RSV Test} | CW180006 | Decision Summary | 11/23/2018 |
| Quidel Sofia 2 (Fingerstick whole blood) | CW170015 | Decision Summary | 08/30/2018 |
| Cepheid Gene Xpert Xpress System {Xpert Flu/RSV Xpress} | CW180002 | Decision Summary | 07/24/2018 |
| StatStrip Glucose Hospital Meter System | CW180005 | Decision Summary | 07/12/2018 |
| Cepheid Gene Xpert Xpress System (Xpert Xpress Strep A) | CW170014 | Decision Summary | 04/26/2018 |
| Alere i System (Alere i Influenza A & B 2) | CW170013 | Decision Summary | 03/23/2018 |
| Mesa Biotech Accula Flu A/Flu B Assay | CW170007 | Decision Summary | 02/06/2018 |
| ACON Laboratories Inc., Mission Cholesterol Pro Monitoring System {Mission Cholesterol Pro Test Cartridges} | CW170010 | Decision Summary | 01/19/2018 |
| Quidel Sofia 2 {Sofia Strep A+ FIA} (from throat swab only) | CW170009 | Decision Summary | 12/21/2017 |
| Cepheid Gene Xpert Xpress System (Xpert Xpress Flu Assay) | CW170005 | Decision Summary | 12/19/2017 |
| Sysmex XW-100 | CW170012 | Decision Summary | 11/06/2017 |
| Alere, BinaxNOW Influenza A & B Card 2 {With Reader} (Direct Nasal and NP Swabs) | CW170003 | Decision Summary | 10/02/2017 |
| Quidel Sofia 2 (Sofia RSV FIA) | CW170001 | Decision Summary | 06/28/2017 |
| Quidel Sofia 2 (Sofia Influenza A+B FIA) | CW160016 | Decision Summary | 05/30/2017 |