Cleared Traditional

K922887 - CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM

K922887 is an FDA 510(k) clearance for CRYP CHECK IN-VITRO COAGULATION CONTROL..., manufactured by Precision Biologicals, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K922887

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
Combination Product No
PCCP Authorized No
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.

GGN Device Classification - Class 2, Special Controls

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 91
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