Cleared Traditional

K882456 - COAG-I PT TEST CARD

K882456 is the FDA 510(k) clearance for COAG-I PT 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 72-day FDA review.

K882456 · Cardiovascular Diagnostic Services · Hematology device
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Aug 1988
Decision
72d
Days
Class 2
Risk

K882456 is an FDA 510(k) clearance for the COAG-I PT 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 August 25, 1988 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiovascular Diagnostic Services devices

Submission Details

510(k) Number K882456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1988
Decision Date August 25, 1988
Days to Decision 72 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 113d · This submission: 72d
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 K882456.
HELENA THROMBOPLASTIN REAGENT
K892050 · Helena Laboratories · Jun 1989
DADE THROMBOPLASTIN IS
K891169 · Baxter Healthcare Corp · Apr 1989
VISION(R) PROTHROMBIN TIME
K883441 · Abbott Laboratories · Sep 1988
SIMPLASTIN EXCEL S
K882214 · Organon Teknika Corp. · Jul 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · Em Diagnostic Systems, Inc. · Feb 1988
THROMBOPLASTIN.C
K874592 · Baxter Healthcare Corp · Feb 1988