Cleared Traditional

K900126 - TT AND HNTT BY HEMOCHRON

K900126 is the FDA 510(k) clearance for TT AND HNTT BY HEMOCHRON by International Technidyne Corp.. It is a Class 2 Hematology device (product code GJA) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K900126 · International Technidyne Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
27d
Days
Class 2
Risk

K900126 is an FDA 510(k) clearance for the TT AND HNTT BY HEMOCHRON. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on February 5, 1990 after a review of 27 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 International Technidyne Corp. devices

Submission Details

510(k) Number K900126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1990
Decision Date February 05, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
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 9
Devices cleared under the same product code (GJA) and FDA review panel - the closest regulatory comparables to K900126.
BC THROMBIN REAGENT
K970645 · Behring Diagnostics, Inc. · May 1997
TEST THROMBIN
K930157 · Behring Diagnostics, Inc. · May 1993
THROMBIN CLOTTING TIME REAGENT
K920147 · Helena Laboratories · May 1992
THROMBIN TIME REAGENT
K894467 · Sigma Chemical Co. · Sep 1989
THROMBIN-PREST REAGENT KIT
K884384 · American Bioproducts Co. · Dec 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
K884385 · American Bioproducts Co. · Dec 1988