Cleared Traditional

K904325 - COAG-1 PT-NC TEST CARD

K904325 is the FDA 510(k) clearance for COAG-1 PT-NC TEST CARD by Cardiovascular Diagnostic Services. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K904325 · Cardiovascular Diagnostic Services · Hematology device
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Jan 1991
Decision
127d
Days
Class 2
Risk

K904325 is an FDA 510(k) clearance for the COAG-1 PT-NC TEST CARD. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Cardiovascular Diagnostic Services (Research Triangle Park, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - 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 Cardiovascular Diagnostic Services devices

Submission Details

510(k) Number K904325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1990
Decision Date January 25, 1991
Days to Decision 127 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 113d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 - GJS Test, Time, Prothrombin

All 95
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K904325.
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
K911995 · International Technidyne Corp. · Jul 1991
HELENA THROMBOPLASTIN REAGENT WITH DILUENT
K905807 · Helena Laboratories · Apr 1991
HELENA THROMBOPLASTIN REAGENT, MODIFICATION
K905857 · Helena Laboratories · Feb 1991
HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION
K904454 · International Technidyne Corp. · Dec 1990
ACS ONE-STAGE PROTHROMBIN TIME REAGENT
K902468 · Analytical Control Systems, Inc. · Aug 1990
THROMBOPLASTIN WITH CALCIUM
K902096 · Sigma Chemical Co. · Jul 1990