Cleared Traditional

K896625 - THROMBOPLASTIN

K896625 is the FDA 510(k) clearance for THROMBOPLASTIN by Medical Diagnostic Technologies, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K896625 · Medical Diagnostic Technologies, Inc. · Hematology device
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Dec 1989
Decision
20d
Days
Class 2
Risk

K896625 is an FDA 510(k) clearance for the THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on December 11, 1989 after a review of 20 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 Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K896625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date December 11, 1989
Days to Decision 20 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
93d faster than avg
Panel avg: 113d · This submission: 20d
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 96
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K896625.
ACS ONE-STAGE PROTHROMBIN TIME REAGENT
K902468 · Analytical Control Systems, Inc. · Aug 1990
THROMBOPLASTIN WITH CALCIUM
K902096 · Sigma Chemical Co. · Jul 1990
THROMBOPLASTIN.C PLUS
K901325 · Baxter Healthcare Corp · May 1990
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · International Technidyne Corp. · Jun 1989
HELENA THROMBOPLASTIN REAGENT
K892050 · Helena Laboratories · Jun 1989
DADE THROMBOPLASTIN IS
K891169 · Baxter Healthcare Corp · Apr 1989