MassTrak Immunosuppressants Kit

510(k) Number

K063868 ↗

FDA Product Code

MLM

Device Class

Class II

Regulation

21 CFR Part 862.1678

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class B

  CE/IVDR

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  Class A

  CE/IVDR

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  Class I

  FDA 510(k) K980180 Active Cleared 12 Feb 1998

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  Class I

  FDA 510(k) K961557 Active Cleared 5 Jul 1996

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  Class I

  FDA 510(k) K962574 Active Cleared 22 Jul 1996

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  Class I

  FDA 510(k) K964588 Active Cleared 29 Nov 1996

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• What clinical setting is the MassTrak Immunosuppressants Kit designed for, and what type of patients is it intended to monitor?

  The MassTrak Immunosuppressants Kit is designed for clinical chemistry laboratories and is specifically intended for monitoring tacrolimus (FK506/Prograf) levels in whole blood samples. It supports therapeutic drug monitoring (TDM) to optimize patient outcomes in transplant care, particularly for kidney and liver transplant recipients.

• Is the MassTrak Immunosuppressants Kit single-use or reusable, and how should it be stored?

  The MassTrak Immunosuppressants Kit is supplied as a single-use reagent set, meaning each kit is intended for one use only. Storage and handling follow standard in vitro diagnostic (IVD) protocols to ensure accuracy and reliability, though specific storage instructions are not detailed in the provided data.

• What type of assay does the MassTrak Immunosuppressants Kit use, and what is its primary purpose?

  The MassTrak Immunosuppressants Kit uses an enzyme immunoassay (EIA) method for quantitative analysis of immunosuppressive drugs, specifically tacrolimus. Its primary purpose is to measure drug levels in whole blood samples, aiding in therapeutic drug monitoring (TDM) to help clinicians optimize immunosuppressive therapy for transplant patients.

• What regulatory pathways has the MassTrak Immunosuppressants Kit followed, and what does this mean for its use?

  The MassTrak Immunosuppressants Kit has followed the FDA 510(k) clearance pathway and is compliant with the In Vitro Diagnostic Regulation (IVDR). This means it has been evaluated for substantial equivalence to a predicate device and meets regulatory requirements for safety, performance, and clinical chemistry applications in the U.S. market.