Cleared Traditional

CRYOCHECK CLOT C (K040987) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040987 · Precision Biologic, Inc. · Hematology device
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Jun 2004
Decision
64d
Days
Class 2
Risk

K040987 is an FDA 510(k) clearance for the CRYOCHECK CLOT C. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Precision Biologic, Inc. (Dartmouth, N.S., CA). The FDA issued a Cleared decision on June 18, 2004 after a review of 64 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Precision Biologic, Inc. devices

Submission Details

510(k) Number K040987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2004
Decision Date June 18, 2004
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 91
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K040987.
HEMOSIL PROTEIN C
K062430 · Instrumentation Laboratory CO · Sep 2006
HEMOSIL PROS
K053499 · Instrumentation Laboratory CO · Jan 2006
COATEST SP FVIII
K042576 · Instrumentation Laboratory CO · Dec 2004
HEMOSIL VON WILLEBRAND ACTIVITY
K040843 · Instrumentation Laboratory CO · Apr 2004
MODIFICATION TO COATEST FACTOR VIII
K033631 · Instrumentation Laboratory CO · Dec 2003
PROTEIN S AC
K022290 · Dade Behring, Inc. · Aug 2002