Cleared Traditional

K923220 - THROMBIN CLOT TIME TEST PROCEDURE

K923220 is an FDA 510(k) clearance for THROMBIN CLOT TIME TEST PROCEDURE, manufactured by Medical Laboratory Automation Systems, Inc.. The device is a Class 2 Hematology device with product code GJA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K923220 · Medical Laboratory Automation Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
90d
Days
Class 2
Risk

K923220 is an FDA 510(k) clearance for the THROMBIN CLOT TIME TEST PROCEDURE. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on September 29, 1992 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Laboratory Automation Systems, Inc. devices

FDA 510(k) Submission Details - K923220

510(k) Number K923220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date September 29, 1992
Days to Decision 90 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
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJA Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (GJA) and FDA review panel - the closest regulatory comparables to K923220.
BC THROMBIN REAGENT
K970645 · Behring Diagnostics, Inc. · May 1997
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