Cleared Traditional

K922887 - CRYP CHECK IN-VITRO COAGULATION CONTROL...

K922887 is the FDA 510(k) clearance for CRYP CHECK IN-VITRO COAGULATION CONTROL... by Precision Biologicals, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K922887 · Precision Biologicals, Inc. · Hematology device
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Feb 1993
Decision
254d
Days
Class 2
Risk

K922887 is an FDA 510(k) clearance for the CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on February 25, 1993 after a review of 254 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Biologicals, Inc. devices

Submission Details

510(k) Number K922887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1992
Decision Date February 25, 1993
Days to Decision 254 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 113d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 56
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K922887.
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691 · International Technidyne Corp. · Mar 1995
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860 · Helena Laboratories · Sep 1994
COAGULATION A.R.P.
K933277 · Helena Laboratories · Mar 1994
CLIBRATION PLASMAS
K924404 · Behring Diagnostics, Inc. · Dec 1992
COAG-CONTROL [N] KIT
K922174 · American Bioproducts Co. · Oct 1992
THROMBO-CALIBRATOR KIT
K921344 · American Bioproducts Co. · Jun 1992