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                In Vitro Diagnostics

In Vitro Diagnostics

                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
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          In Vitro Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin InterferenceIn Vitro Diagnostics Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
  
  	
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    PrintHealth 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
			K014105INTERNATIONAL POINT OF CARE INC.
			Cardiac STATus
			SPECTRAL'S 2 IN 1 (TNI-MYO)
			K020950NANO-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
			K050975NANO-DITECH CORPORATION
			Nano-CheckTM AMI cTnI Test
			NANO-CHECK AMI CTNI CARDIAC MARKER TEST
			K102131NANO-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
			K102441Ortho-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
			K062838PRINCETON BIOMEDITECH CORP.
			LifeSign MI Myoglobin/Troponin I
			LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
			K022946PRINCETON BIOMEDITECH CORP.
			LifeSign MI Troponin I
			CARDIAC STATUS TROPONIN I
			K963513PRINCETON BIOMEDITECH CORP.
			LifeSign MI CK-MB/Myoglobin/Trop I
			CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
			K981882ROCHE 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
			K000784ROCHE DIAGNOSTICS GMBH
			Elecsys Troponin T STAT
			ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
			K051752ROCHE DIAGNOSTICS GMBH
			Elecsys Troponin I; Elecsys Troponin I STAT
			ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
			K082699ROCHE 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
			K162895ROCHE DIAGNOSTICS GMBH
			ELECSYS TROPONIN T
			ELECSYS TROPONIN T
			K961500Siemens Healthcare Diagnostics Inc.
			ADVIA Centaur TnI-Ultra; Atellica IM TnI-Ultra
			TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
			K053020SIEMENS HEALTHCARE DIAGNOSTICS INC.
			Dimension Vista CTNI Flex reagent cartridge
			DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
			K063756SIEMENS 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

                                                                                  Content current as of:
      06/21/2022
              
              
Regulated Product(s)
		 Medical DevicesIn Vitro Diagnostics

          
                        Companion Diagnostics
          Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
          Direct-to-Consumer Tests
          Nucleic Acid Based Tests


                        Blood Glucose Monitoring Devices
          Drugs of Abuse Tests
          Home Use Tests
          Laboratory Developed Tests
          Precision Medicine
          Tests Used In Clinical Care
          Warfarin INR Test Meters
 
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