Cleared Traditional

K962857 - COAG-A-MATE MTX

K962857 is an FDA 510(k) clearance for COAG-A-MATE MTX, manufactured by Organon Teknika Corp.. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K962857 · Organon Teknika Corp. · Hematology device
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Jan 1997
Decision
184d
Days
Class 2
Risk

K962857 is an FDA 510(k) clearance for the COAG-A-MATE MTX. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 184 days - an extended review 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: 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K962857

510(k) Number K962857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date January 22, 1997
Days to Decision 184 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
71d slower than avg
Panel avg: 113d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKP Device Classification - Class 2, Special Controls

Product Code GKP Instrument, Coagulation, Automated
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 - GKP Instrument, Coagulation, Automated

All 37
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K962857.
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K992321 · Dade Behring, Inc. · Sep 1999
COAG-A-MATE MAX
K991101 · Organon Teknika Corp. · Jun 1999
SYSMEX CA-6000
K964139 · Dade Intl., Inc. · Feb 1997
ACL 6000 SYSTEM (ACL 6000)
K961991 · Instrumentation Laboratory CO · Sep 1996
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · American Bioproducts Co. · Jul 1996
PROTIME MICROCOAGULATION SYSTEM
K951072 · International Technidyne Corp. · Oct 1995