Cleared Traditional

K924425 - PROTEIN C REAGENT, COAGULOMETRIC

K924425 is an FDA 510(k) clearance for PROTEIN C REAGENT, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 875-day FDA review.

K924425 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
875d
Days
Class 2
Risk

K924425 is an FDA 510(k) clearance for the PROTEIN C REAGENT, COAGULOMETRIC. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 875 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

FDA 510(k) Submission Details - K924425

510(k) Number K924425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date January 24, 1995
Days to Decision 875 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
762d slower than avg
Panel avg: 113d · This submission: 875d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 189
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K924425.
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K924425 · PROTEIN C REAGENT, COAGULOMETRIC
Download PDF FDA Summary Behring Diagnostics, …