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 |
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BioMérieux | BioFire Blood Culture Identification 2 (BCID2) Panel | This multiplex PCR assay is used to identify in blood culture samples Gram-positive and Gram-negative bacteria, yeasts, and genetic markers of antimicrobial resistance, with results in about one hour. |
12/20/2024 |
Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 µg/mL | The antimicrobial susceptibility test powder is used to aid the identification of resistance to Ceftobiprole, which is used in the treatment of Staphylococcus aureus infections |
12/19/2024 |
Cepheid | Xpert MRSA/SA SSTI | The automated real-time PCR test is used to aid the detection of Staphylococcus aureus and methicillin-resistant S. aureus in swab samples from skin and soft tissue infections. |
12/18/2024 |
Roche | Roche Digital Pathology Dx | The Roche Digital Pathology Dx whole-slide imaging system can now be used with the firm's Ventana DP 600 slide scanner. The system was cleared in June 2024 for use with the Ventana DP 200 slide scanner, and the system also includes Roche's digital pathology workflow software and the ASUS PA248QV display. |
12/17/2024 |
Healgen Scientific | Healgen Accurate Multi-Drug Urine Drug Screen Cup, Healgen Accurate Home Multi-Drug Urine Test Cup | The 18-target lateral flow immunoassays are used to aid the detection of drugs of abuse. |
12/17/2024 |
Inova Diagnostics | Aptiva APS IgG Reagent, Aptiva APS IgM Reagent | The immunoassays are used to aid the diagnosis of primary and secondary antiphospholipid syndrome through the semi-quantitative determination of anti-cardiolipin and anti-beta 2 glycoprotein 1 IgG and IgM autoantibodies in serum. |
12/17/2024 |
Microgenics | Alinity C Benzodiazepines Reagent Kit | The urine-based immunoassay is used for the detection of benzodiazepines and their metabolites. |
12/11/2024 |
Abbott Laboratories | Alinity M SARS-CoV-2 | The RT-PCR assay is used for the qualitative detection of SARS-CoV-2 nucleic acids in nasopharyngeal or anterior nasal swab samples from patients with signs and symptoms of COVID-19 |
12/06/2024 |
Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 µg/mL | The antimicrobial susceptibility test powder is used to aid the identification of resistance to Linezolid, which is used in the treatment of certain Enterococcus faecium, E. faecalis, S. aureus, S. epidermidis, and S. haemolyticus infections. |
12/05/2024 |
BioMérieux | BioFire FilmArray Tropical Fever Panel | The automated qualitative PCR test is used for the detection of bacterial, viral, and parasitic nucleic acids in EDTA whole blood samples from patients with signs or symptoms of acute febrile illness or suspected exposure to chikungunya virus, dengue virus serotypes 1-4, Leptospira species, and Plasmodium species. |
12/05/2024 |
Medical Electronic Systems | YO Home Sperm Test | The smartphone-based, over-the-counter test is for semen analyis for quantifying total sperm concentration, total motile/motility, progressive motility, motile sperm concentration, and progressively motile sperm concentration. |
11/29/2024 |
Thermo Fisher Scientific | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | The IVD system is for clinical susceptibility testing of non-fastidious Gram-negative isolates and of non-fastidious Gram-negative isolates. |
11/26/2024 |
Nova Biomedical | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | The test is for quantitatively determining glycated hemoglobin percentage in capillary whole blood obtained from the fingertip. The results are for monitoring long-term blood glucose and metabolic control in patients with diabetes mellitus. |
11/22/2024 |
Cepheid | Xpert vanA | The clearance is an update to a previous clearance. According to the FDA document, the indications for use of the device has changed, along with the proposed labeling. The assay is now for use with Cepheid's GeneXpert instruments, including the new GeneXpert Infinity platform. |
11/21/2024 |
Nova Biomedical | Nova Allegro UACR Assay, Nova Allegro Analyzer | The assay is for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio in urine for the early diagnosis of nephropathy. It is for use in clinical laboratories and near-patient testing settings. |
11/19/2024 |
Hologic | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | The fully automated, multiplexed, real-time PCR-based IVD test is for qualitatively detecting and differentiating among SARS-CoV-2, influenza A/B, and RSV.
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11/15/2024 |
Hangzhou Clongene Biotech | Clungene Fentanyl Home Test Cassette; Clungene Fentanyl Test Cassette | The lateral flow immunochromatographic assay is for the quantitative detection of fentanyle in urine at the cutoff concentration of 1.0 ng/mL. It provides only a preliminary result and a more specific alternative methods must be used for confirmed analytical result, the FDA said. |
11/08/2024 |
BioFire Diagnostics | BioFire FilmArray Gastrointestinal (GI) Panel | The multiplexed nucleic acid-based test is for use with the FilmArray 2.0 System or the Torch System for the qualitative detection and identification of multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals showing signs and symptoms of gastrointestinal infection. |
11/07/2024 |
Becton Dickinson | BD Vacutainer Citrate Blood Collection Tubes | The single-use blood collection tubes are used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing in settings where a venous blood sample is collected by a trained healthcare worker. |
10/31/2024 |
Microgenics | DRI Ecstasy Plus Assay | The homogenous enzyme immunoassay is intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. |
10/30/2024 |