FDA product code MKT: Hepatitis Viral B Dna Detection

MKT is the FDA product code for hepatitis viral b dna detection. It is a Class II device, regulated under 21 CFR 866.3174 and reviewed by the Microbiology panel. Devices under MKT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 7 recalls for MKT devices, 2 initiated in the last five years.

Definition

Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.

Classification

Recalls for MKT devices

7 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-03-04.

Frequently asked questions

What is FDA product code MKT?

MKT is the FDA product code for hepatitis viral b dna detection. It is a Class II device, regulated under 21 CFR 866.3174 and reviewed by the Microbiology panel.

What device class is MKT?

Class II, regulation 21 CFR 866.3174. Typical premarket route: 510(k).

Have MKT devices been recalled?

Yes: 7 product recalls across 6 recall events; the most recent began 2022-03-04.

Next steps

• Run an FDA pathway report with predicate devices for product code MKT
• Run a recall and safety report across every MKT manufacturer
• Watch product code MKT for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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