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US Food and Drug Administration 510(k) Clearance Tracker: In Vitro Diagnostic Tests and Instruments

Each month the FDA clears numerous medical devices for marketing in the US, including many IVD tests and instruments. We are curating the FDA database for those clearances that are of interest to IVD developers. clinicians, and those who are interested in the market. The tracker will be updated on a monthly basis. Please keep in mind there is a lag time between when a product is cleared by the FDA and when the agency will include that information in its database, but if you are an IVD developer with a device that was cleared by FDA that was not included in the tracker, please contact us at [email protected]

Company Device Name Description Date of Clearance Sort ascending
Nantong Egens Biotechnology Egens Pregnancy Test Midstream I, Egens Pregnancy Test Midstream II

The lateral flow chromatographic immunoassays qualitatively detect human chorionic gonadotropin to help detect early pregnancy. 

Hologic Aptima Neisseria Gonorrhoeae Assay

The nucleic acid amplification test detects RNA from Neisseria gonorrhoeae to diagnose gonococcal urogenital disease from male urine specimens using Hologic's Panther system.

Nano-Ditech Nano-Check COVID-19 Antigen Test

The lateral flow immunochromatographic assay qualitatively detects SARS-CoV-2 nucleoprotein antigens in anterior nasal swab specimens from people with signs and symptoms of upper respiratory infection when testing is started within four days of symptom onset. 

Becton Dickinson BD Vacutainer Fluoride Blood Collection Tubes

The blood collection tubes are evacuated, sterile, single-use tubes available with sodium fluoride/potassium oxalate or sodium fluoride/Na2EDTA that are intended for the collection, containment, preservation, transportation, and centrifugation of venous blood specimens for in vitro diagnostic testing.

Siemens HealthCare Diagnostics Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2)

The assay is intended to quantitatively determine the concentration of C-reactive protein in human serum and plasma on the Atellica CH Analyzer.

Co-Innovation Biotech Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

The four tests are rapid screening assays for the detection of marijuana and its metabolites in human urine at cutoff concentrations of 20ng/mL and 50ng/mL and are in either test strip or dipcard format. 

Hangzhou Laihe Biotech Lyher Urine Marijuana (THC) Test Kit (Strip), Lyher Urine Marijuana (THC) Test Kit (Cassette)

The rapid lateral flow immunoassays qualitatively detect THC-COOH in human urine with either a test strip or cassette device, providing a preliminary result that must be confirmed with a more specific alternate chemical method. 

Hangzhou Laihe Biotech Lyher Urine Multi-Drug Test Kit (Cup), Lyher Urine Multi-Drug Test Kit (Cassette), Lyher Urine Multi-Drug Test Kit (Dipcard)

The rapid lateral flow immunoassays qualitatively detect d-amphetamine, d-methamphetamine, benzoylecgonine, morphine, phencyclidine, and THC-COOH in human urine and can consist of the listed analytes in any combination, up to a maximum of six analytes. 

Sysmex America Sysmex XQ Series (XQ-320) Automated Hematology Analyzer

The quantitative multi-parameter analyzer is used to analyze venous and capillary whole blood samples.

QuidelOrtho Savanna, Savanna HSV 1+2/VZV Assay

The instrument is a real-time PCR-based automated molecular diagnostics instrument for the analysis of up to 12 pathogens or targets, plus four controls. The Savanna HSV 1+2/VZV Assay is used for the detection and differentiation of HSV-1, HSV-2, and varicella-zoster virus nucleic acids from cutaneous or mucocutaneous lesion specimens.

Beckman Coulter Access hsTnI

The test is used for the determination of cardiac troponin I levels in serum and plasma to aid in the diagnosis of myocardial infarction. The modification is a switch to the Lumi-Phos PRO substrate from the Lumi-Phos 530 substrate. This assay is designed for use on the firm's DxI 9000 Access Immunoassay Analyzer.

Immunexpress Septicyte Rapid

The firm gained clearance for EDTA blood-compatible cartridges that are designed for use with the firm's RT-qPCR SeptiCyte Rapid test to differentiate sepsis from infection-negative systemic inflammation.

Biomerica Hp Detect Stoool Antigen ELISA

The enzyme immunoassay is used for the qualitative detection of H. pylori antigen in stool or fecal samples.

Guangzhou Decheng Biotechnology Dochek Multi-Drug Urine Test Cup Rx, Dochek Multi-Drug Urine Test Cup

The qualitative lateral flow immunoassays are used for the detection in urine of drugs of abuse.

Instrumentation Laboratory HemosIL Chromagenic Factor IX

The automated chromagenic assay is used for quantitative determination of factor IX activity in 3.2 percent citrated plasma, and it is designed for use with Instrumentation Laboratory's ACL TOP Family and ACL TOP Family 50 Series instruments.

Siemens Healthineers N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

This clearance is for a labeling modification to include a high-dose hook effect claim for N antiserum to immunoglobulins IgG for cerebrospinal fluid samples. The assay is used to aid in the diagnosis of abnormal protein metabolism and the inability to resist infectious agents.

MedMira Laboratories Reveal G4 Rapid HIV-1/2 Antibody Test

The clearance allows an HIV-2 claim for the rapid antigen test for HIV-1/2 detection. This test is a vertical flow assay that uses gravity to move fluid through the assay, compared to the capillary reaction used to move fluid through lateral flow assays.

Hangzhou AllTest Biotech AllTest Multi-Drug Rapid Test Cup, AllTest Multi-Drug Rapid Test Panel, AllTest Multi-Drug Rapid Test Cup Rx, and AllTest Multi-Drug Rapid Test Panel Rx

The qualitative lateral flow immunoassays are used for the detection in urine of drugs of abuse.

QuidelOrtho Sofia 2 SARS Antigen+ FIA

The lateral flow immunofluorescent sandwich assay is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab samples from patients with signs and symptoms of upper respiratory infection. The clearance is a modification that is intended to clarify when serial testing is needed and how to interpret the test results.

Qurasense Q-Pad Test System

The Q-Pad Kit is used to collect menstrual blood samples, and the Q-Pad A1c Test is used for the quantitative measurement of hemoglobin A1c using menstrual blood to aid in the monitoring of long-term control of blood sugar in women with diabetes.