Cleared Traditional

K990579 - CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)

K990579 is an FDA 510(k) clearance for CRYOCHECK LA CHECK, manufactured by Precision Biologic. The device is a Class 1 Hematology device with product code GIR cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K990579 · Precision Biologic · Hematology device
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Jul 1999
Decision
150d
Days
Class 1
Risk

K990579 is an FDA 510(k) clearance for the CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML). Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on July 23, 1999 after a review of 150 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8950 - 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 Biologic devices

FDA 510(k) Submission Details - K990579

510(k) Number K990579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date July 23, 1999
Days to Decision 150 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
37d slower than avg
Panel avg: 113d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

GIR Device Classification - Class 1, General Controls

Product Code GIR Reagent, Russel Viper Venom
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8950
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GIR Reagent, Russel Viper Venom

All 9
Devices cleared under the same product code (GIR) and FDA review panel - the closest regulatory comparables to K990579.
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
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ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
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CRYOCHECK LA SURE, MODEL SUR25-10
K990580 · Precision Biologic · Jul 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
K990302 · Instrumentation Laboratory CO · Apr 1999
DIA REPTIN
K841365 · Diatech, Inc. · Jun 1984