Cleared Traditional

K970645 - BC THROMBIN REAGENT

K970645 is the FDA 510(k) clearance for BC THROMBIN REAGENT by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code GJA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K970645 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
88d
Days
Class 2
Risk

K970645 is an FDA 510(k) clearance for the BC THROMBIN REAGENT. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on May 19, 1997 after a review of 88 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K970645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date May 19, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
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 K970645.
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · Sigma Diagnostics, Inc. · Oct 1998
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
K925493 · Biomerieux Vitek, Inc. · Apr 1994
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 TIME REAGENT
K894467 · Sigma Chemical Co. · Sep 1989