Cleared Traditional

K790323 - COAG-A-MATE 2001

K790323 is the FDA 510(k) clearance for COAG-A-MATE 2001 by General Diagnostics. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K790323 · General Diagnostics · Hematology device
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Mar 1979
Decision
34d
Days
Class 2
Risk

K790323 is an FDA 510(k) clearance for the COAG-A-MATE 2001. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K790323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1979
Decision Date March 21, 1979
Days to Decision 34 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 113d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K790323.
MULTI CLOT-#819
K812122 · Volu Sol Medical Industries · Nov 1981
NORM-TROL
K792310 · Helena Laboratories · Dec 1979
ELVI 818 DIGICLOT MULTISCAN
K791586 · Volu Sol Medical Industries · Sep 1979
PLASMA, STANDARDIZED NORMAL
K790204 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1979
TPC-LYOPHILIZED POOLED HUMAN PLASMA
K761091 · Bio/Data Corp. · Feb 1977
VERONAL BUFFER
K761171 · Bio/Data Corp. · Jan 1977