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  5. Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
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Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference

Health care providers, lab personnel, and lab test developers should be aware that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.

The FDA has issued an updated safety communication, UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests, that discusses concerns with biotin interference in certain laboratory tests and provides recommendations for consumers, health care providers, lab personnel and lab test manufacturers and developers. Since the 2017 safety communication, some lab test developers have been successful at mitigating the biotin interference of their assays, but others have not yet addressed it.

The FDA remains concerned about certain laboratory tests that have not addressed the risk of biotin interference. For example, the FDA has continued to receive adverse events reports indicating biotin interference caused falsely low troponin results.  In an effort to increase transparency about this clinically important interference, the FDA has decided to notify the public about troponin assays that have not addressed the risk of biotin interference.

The following table lists the FDA listed troponin In Vitro Diagnostic Devices that are subject to biotin interference but have not addressed this risk.

Registered Establishment Name Assay Trade Name(s)/ Listed Name(s) 510(k) Cleared Device Name 510(k)
INTERNATIONAL POINT OF CARE INC. Cardiac STATus SPECTRAL'S TROPONIN I K014105
INTERNATIONAL POINT OF CARE INC. Cardiac STATus SPECTRAL'S 2 IN 1 (TNI-MYO) K020950
NANO-DITECH CORPORATION Nano-CheckTM AMI 3 IN 1 cTnI/CK-MB/Myo Test NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN K050975
NANO-DITECH CORPORATION Nano-CheckTM AMI cTnI Test NANO-CHECK AMI CTNI CARDIAC MARKER TEST K102131
NANO-DITECH CORPORATION Nano-CheckTM AMI 2 IN 1 cTnI/Myo Test Nano-Check AMI 2 IN 1 Cardiac Marker Test, cTnI and Myoglobin; NANO-CHECK AMI 2 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I AND MYOGLOBIN K102441
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Troponin I ES Reagent Pack; VITROS Immunodiagnostic Products Troponin I ES Calibrators; VITROS Immunodiagnostic Products Troponin I ES Range Verifiers VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 K062838
PRINCETON BIOMEDITECH CORP. LifeSign MI Myoglobin/Troponin I LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST K022946
PRINCETON BIOMEDITECH CORP. LifeSign MI Troponin I CARDIAC STATUS TROPONIN I K963513
PRINCETON BIOMEDITECH CORP. LifeSign MI CK-MB/Myoglobin/Trop I CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST K981882
ROCHE DIAGNOSTICS GMBH CARDIAC Control Troponin-T; Cardiac Reader IQC; CARDIAC READER SYSTEM; Cardiac T Quantitative 10Tests; ROCHE CARDIAC TEST STRIP TROPONIN T; TROPT Sensitive 5 Tests THE CARDIAC READER SYSTEM K000784
ROCHE DIAGNOSTICS GMBH Elecsys Troponin T STAT ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) K051752
ROCHE DIAGNOSTICS GMBH Elecsys Troponin I; Elecsys Troponin I STAT ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS K082699
ROCHE DIAGNOSTICS GMBH Elecsys Troponin T Gen 5 STAT Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 K162895
ROCHE DIAGNOSTICS GMBH ELECSYS TROPONIN T ELECSYS TROPONIN T K961500
Siemens Healthcare Diagnostics Inc. ADVIA Centaur TnI-Ultra; Atellica IM TnI-Ultra TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM K053020
SIEMENS HEALTHCARE DIAGNOSTICS INC. Dimension Vista CTNI Flex reagent cartridge DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE K063756
SIEMENS HEALTHCARE DIAGNOSTICS INC. Dimension EXL LOCI Module TNI Flex reagent cartridge DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 K081643
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