Cleared Traditional

COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE (K885076) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K885076 · Organon Teknika Corp. · Hematology device
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Dec 1988
Decision
22d
Days
Class 2
Risk

K885076 is an FDA 510(k) clearance for the COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on December 30, 1988 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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

Submission Details

510(k) Number K885076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1988
Decision Date December 30, 1988
Days to Decision 22 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
91d faster than avg
Panel avg: 113d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 72
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K885076.
HEPARIN ADSORBENT
K912061 · Sigma Diagnostics, Inc. · Jul 1991
COAG-A-MATE - RA4
K900917 · Organon Teknika Corp. · Apr 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · Baxter Healthcare Corp · Mar 1990
OWREN'S VERONAL BUFFER
K883484 · Helena Laboratories · Aug 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
K881367 · Instrumentation Laboratory CO · Jun 1988
CHROM-TROL
K872377 · Helena Laboratories · Jul 1987