Cleared Traditional

K870596 - PROTHROMBIN TIME TEST

K870596 is the FDA 510(k) clearance for PROTHROMBIN TIME TEST by U. S. Diagnostics, Inc.. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K870596 · U. S. Diagnostics, Inc. · Hematology device
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Apr 1987
Decision
69d
Days
Class 2
Risk

K870596 is an FDA 510(k) clearance for the PROTHROMBIN TIME TEST. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on April 20, 1987 after a review of 69 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 U. S. Diagnostics, Inc. devices

Submission Details

510(k) Number K870596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date April 20, 1987
Days to Decision 69 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 113d · This submission: 69d
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 K870596.
THROMBOPLASTIN.C
K874592 · Baxter Healthcare Corp · Feb 1988
PROTHROMBIN TIME TEST
K872537 · Sclavo, Inc. · Aug 1987
THROMBOREL S
K872844 · Behring Diagnostics, Inc. · Aug 1987
PROTIME AUTOMATE TEST KIT
K864392 · American Bioproducts Co. · Jan 1987
SIMPLASTIN EXCEL
K864283 · Organon Teknika Corp. · Dec 1986
THROMBOPLASTIN.FS
K864272 · American Dade · Nov 1986