Prototro/Proteolytic Enzyme Control

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K831297 ↗

FDA Product Code

JBQ

Device Class

Class II

Regulation

21 CFR Part 864.7060

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Proteolytic Enzyme Control used for in laboratory testing?

  The Proteolytic Enzyme Control is designed for quality assurance in laboratory assays that measure antithrombin III levels. It serves as a reference standard to monitor and validate the performance of proteolytic enzyme-based tests, ensuring the accuracy and reliability of patient sample measurements in hematology diagnostics.

• How is the Proteolytic Enzyme Control supplied and intended for use?

  This device is supplied as a ready-to-use reagent, meaning no additional preparation is required before use. It is intended exclusively for single-use in clinical laboratories to maintain consistency and sterility in diagnostic testing.

• What storage conditions are required for the Proteolytic Enzyme Control?

  The control does not require special storage conditions beyond standard refrigeration. This ensures stability and usability while minimizing the risk of degradation or contamination before use.

• Is the Proteolytic Enzyme Control reusable or designed for single-use?

  The device is explicitly designed for single-use only. This design choice helps prevent cross-contamination between tests and ensures consistent, reliable results for each assay.

• What regulatory pathway does the Proteolytic Enzyme Control follow?

  The Proteolytic Enzyme Control was granted FDA 510K clearance under the product code JBQ, with a decision of Substantially Equivalent (SESE) by the Hematology Advisory Committee. It falls under Class II regulatory controls and was cleared in 1983, ensuring compliance with U.S. regulatory standards for in vitro diagnostic devices.