Cleared Traditional

K881281 - COAG-A-MATE XM

K881281 is an FDA 510(k) clearance for COAG-A-MATE XM, 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 54-day FDA review.

K881281 · Organon Teknika Corp. · Hematology device
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May 1988
Decision
54d
Days
Class 2
Risk

K881281 is an FDA 510(k) clearance for the COAG-A-MATE(R) XM. 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 May 18, 1988 after a review of 54 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.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K881281

510(k) Number K881281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1988
Decision Date May 18, 1988
Days to Decision 54 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
59d faster than avg
Panel avg: 113d · This submission: 54d
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 K881281.
CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430
K901380 · Helena Laboratories · May 1990
KOAGULAB 60-S COAGULATION SYSTEM
K901120 · Ortho Diagnostic Systems, Inc. · May 1990
KOAGULAB* 32-S COAGULATION SYSTEM
K885035 · Ortho Diagnostic Systems, Inc. · Feb 1989
COAG-A-MATE X2
K813564 · General Diagnostics · Jan 1982