Cleared Traditional

K900685 - CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

K900685 is an FDA 510(k) clearance for CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER, manufactured by Texas Intl. Laboratories, Inc.. The device is a Class 2 Hematology device with product code KQG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K900685 · Texas Intl. Laboratories, Inc. · Hematology device
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Apr 1990
Decision
63d
Days
Class 2
Risk

K900685 is an FDA 510(k) clearance for the CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER. Classified as Instrument, Coagulation (product code KQG), Class II - Special Controls.

Submitted by Texas Intl. Laboratories, Inc. (Needham, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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.

FDA 510(k) Submission Details - K900685

510(k) Number K900685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1990
Decision Date April 16, 1990
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQG Device Classification - Class 2, Special Controls

Product Code KQG Instrument, Coagulation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 - KQG Instrument, Coagulation

All 13
Devices cleared under the same product code (KQG) and FDA review panel - the closest regulatory comparables to K900685.
PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321 · Pacific Hemostasis · Jun 1999
HEMOCHRON RESPONSE
K983475 · International Technidyne Corp. · May 1999
ELVI 828 DIGICLOT MULTISCAN
K902614 · Logos Scientific, Inc. · Nov 1990
COAGULATOR (8 CHANNEL)
K862047 · Med USA · Sep 1986
COAGULATOR
K852492 · Med USA · Aug 1985
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169 · Medical Laboratory Automation Systems, Inc. · Jun 1985
K900685 · CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
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