Stratify JCV DxSelect

• • Terminated Z-1454-2015 FDA Class II ·initiated 15 Mar 2015

  Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results.

510(k) Number

K120986 ↗

FDA Product Code

OYP

Device Class

Class II

Regulation

21 CFR Part 866.3336

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  Class I

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• Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

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See all devices from Focus Diagnostics, Inc. →

• What is the Stratify JCV DxSelect used for?

  The Stratify JCV DxSelect is an in vitro diagnostic assay designed to qualitatively detect antibodies to JC virus in human serum or plasma. It aids clinicians in identifying patients at risk for progressive multifocal leukoencephalopathy (PML), a rare but serious neurological condition linked to JC virus infection. This is particularly useful in specific patient populations, such as those with immunocompromised states.

• How is the Stratify JCV DxSelect supplied and used?

  The Stratify JCV DxSelect is supplied as a single-use assay kit. It requires laboratory processing to perform the test, meaning it must be handled and analyzed in a clinical or research lab setting. The kit is not intended for direct patient administration or use outside of controlled laboratory environments.

• Is the Stratify JCV DxSelect sterile and intended for reuse?

  The Stratify JCV DxSelect is designed as a single-use assay kit, meaning each kit is intended for one test procedure only. Sterility is maintained as part of the in vitro diagnostic assay protocol, ensuring safe handling and use in laboratory settings. Reuse is not recommended or supported by the manufacturer.

• What storage and handling requirements apply to the Stratify JCV DxSelect?

  The Stratify JCV DxSelect must be stored and handled according to standard in vitro diagnostic assay protocols provided by the manufacturer. Proper storage conditions are critical to maintain the integrity and reliability of the assay results. Always follow the manufacturer’s instructions for storage temperature, expiration dates, and handling precautions to ensure accurate and safe testing.

• What regulatory pathway does the Stratify JCV DxSelect follow?

  The Stratify JCV DxSelect is authorized under the FDA’s 510(k) clearance pathway, specifically under clearance number K120986. It is classified as a Class II device under the regulatory code 866.3336 and falls under the Microbiology advisory committee. This classification indicates that it is considered a moderate-risk device requiring regulatory oversight to ensure safety and effectiveness.