Stratify JCV Antibody

No FDA recalls on record, checked 6 Oct 2026.

Full name

Stratify Jcv(Tm) Antibody

De Novo Number

DEN120008 ↗

FDA Product Code

OYP

Device Class

Class II

Regulation

21 CFR Part 866.3336

Advisory Committee

Microbiology

FDA Decision

DENG De Novo granted

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See all devices from Focus Diagnostics, Inc. →

• What is the Stratify JCV Antibody test used for?

  The Stratify JCV Antibody test is designed for the qualitative detection of antibodies to JC virus in human serum or plasma. It aids in risk assessment for progressive multifocal leukoencephalopathy (PML) by identifying anti-JCV antibodies using an enzyme-linked immunosorbent assay (ELISA) method. This is a laboratory-based diagnostic service intended for clinical use in evaluating patient risk.

• How is the Stratify JCV Antibody test supplied and performed?

  The Stratify JCV Antibody test is supplied as a laboratory-based testing service performed at Focus Diagnostics’ Reference Laboratory. It is not a kit for point-of-care use but involves a two-step process: an initial detection ELISA followed by a confirmatory inhibition ELISA for indeterminate results. The assay is intended for single-use diagnostic purposes only.

• Is the Stratify JCV Antibody test reusable or single-use?

  The Stratify JCV Antibody test is intended for single-use diagnostic purposes. The device description explicitly states it has no reusable components and is designed as a one-time laboratory assay. Each test requires a fresh sample and is processed through the two-step ELISA method only once per patient specimen.

• What regulatory pathway was used for the Stratify JCV Antibody test?

  The Stratify JCV Antibody test received FDA 510(k) clearance, as indicated in the AUTHORIZATIONS field and confirmed by the k_number DEN120008 and clearance_type Post-NSE. It is regulated as a Class II device under the microbiology specialty, with no claims of FDA approval or CE marking beyond the 510(k) clearance.

• What type of specimen is required for the Stratify JCV Antibody test?

  The Stratify JCV Antibody test requires human serum or plasma as the specimen type for qualitative detection of anti-JCV antibodies. This is specified in the DESCRIPTION section, which states the assay is designed for use with human serum or plasma in a laboratory setting. No other specimen types are mentioned or implied.