Cleared Traditional

K894467 - THROMBIN TIME REAGENT

K894467 is the FDA 510(k) clearance for THROMBIN TIME REAGENT by Sigma Chemical Co.. It is a Class 2 Hematology device (product code GJA) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K894467 · Sigma Chemical Co. · Hematology device
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Sep 1989
Decision
49d
Days
Class 2
Risk

K894467 is an FDA 510(k) clearance for the THROMBIN TIME REAGENT. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7875 - 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 K894467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date September 05, 1989
Days to Decision 49 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
64d faster than avg
Panel avg: 113d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJA Test, Thrombin Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7875
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 - GJA Test, Thrombin Time

All 16
Devices cleared under the same product code (GJA) and FDA review panel - the closest regulatory comparables to K894467.
TEST THROMBIN
K930157 · Behring Diagnostics, Inc. · May 1993
THROMBIN CLOTTING TIME REAGENT
K920147 · Helena Laboratories · May 1992
TT AND HNTT BY HEMOCHRON
K900126 · International Technidyne Corp. · Feb 1990
THROMBIN-PREST REAGENT KIT
K884384 · American Bioproducts Co. · Dec 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
K884385 · American Bioproducts Co. · Dec 1988
IL SYSTEM 810, ACL AND THE REAGENT SETS
K862301 · Instrumentation Laboratory CO · Sep 1986