Cleared Traditional

K902096 - THROMBOPLASTIN WITH CALCIUM

K902096 is the FDA 510(k) clearance for THROMBOPLASTIN WITH CALCIUM by Sigma Chemical Co.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K902096 · Sigma Chemical Co. · Hematology device
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Jul 1990
Decision
56d
Days
Class 2
Risk

K902096 is an FDA 510(k) clearance for the THROMBOPLASTIN WITH CALCIUM. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 56 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K902096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date July 03, 1990
Days to Decision 56 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
57d faster than avg
Panel avg: 113d · This submission: 56d
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 94
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K902096.
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.C PLUS
K901325 · Baxter Healthcare Corp · May 1990
THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
K896625 · Medical Diagnostic Technologies, Inc. · Dec 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · International Technidyne Corp. · Jun 1989