Cleared Traditional

K954625 - PROTHROMBIN TIME TEST CARD

K954625 is the FDA 510(k) clearance for PROTHROMBIN TIME TEST CARD by Cardiovascular Diagnostics, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K954625 · Cardiovascular Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
166d
Days
Class 2
Risk

K954625 is an FDA 510(k) clearance for the PROTHROMBIN TIME TEST CARD. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on March 11, 1996 after a review of 166 days - an extended review 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: 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 Diagnostics, Inc. devices

Submission Details

510(k) Number K954625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date March 11, 1996
Days to Decision 166 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 113d · This submission: 166d
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 K954625.
COAGUCHEK PST SYSTEM
K962571 · Boehringer Mannheim Corp. · Apr 1997
PROTIME MICROCOAGULATION SYSTEM
K961835 · International Technidyne Corp. · Mar 1997
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · Nova Biomedical Corp. · Jun 1996
THROMBOPLASTIN-LI REAGENT
K951820 · Helena Laboratories · Oct 1995
MDA SIMPLASTIN LS
K952608 · Organon Teknika Corp. · Oct 1995
COAGUCHEK SYSTEM
K942884 · Boehringer Mannheim Corp. · May 1995