Proteolytic Enzyme Control

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K803110 ↗

FDA Product Code

LGP

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What specific type of testing is the Proteolytic Enzyme Control designed to validate in a hematology lab?

  The Proteolytic Enzyme Control is specifically designed to evaluate and monitor the performance of assays that measure alpha-2-antiplasmin levels in hematology testing. It acts as a reference standard to ensure the accuracy and consistency of these diagnostic procedures, helping labs confirm their assay systems are functioning correctly.

• Is this control meant for single-use or repeated use in a laboratory setting?

  This device is explicitly supplied as a single-use reagent, meaning each unit is intended for one-time use in in vitro laboratory testing. It is not designed for reuse, which helps maintain accuracy and prevent cross-contamination in diagnostic workflows.

• How was the regulatory clearance for this device obtained, and what does that mean for its use?

  The Proteolytic Enzyme Control received FDA clearance via the Traditional 510(k) pathway, classified under product code LGP and falling under Class II regulatory controls. This means it was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed for its intended use in hematology testing without further approval.

• What kind of clinical specialty does this control support, and why is it relevant?

  This control supports hematology, a medical specialty focused on blood disorders and coagulation studies. Its relevance lies in ensuring the reliability of assays for alpha-2-antiplasmin, a key protein in blood clotting mechanisms, which is critical for diagnosing and monitoring conditions like bleeding disorders or thrombotic risks.