Cleared Traditional

COATEST(R) APC(TM) RESISTANCE (K945940) - FDA 510(k) Clearance

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

K945940 · Axis-Shield Doc AS · Hematology device
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Aug 1995
Decision
245d
Days
Class 2
Risk

K945940 is an FDA 510(k) clearance for the COATEST(R) APC(TM) RESISTANCE. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by Axis-Shield Doc AS (San Diego, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 245 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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.

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Submission Details

510(k) Number K945940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1994
Decision Date August 07, 1995
Days to Decision 245 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 113d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGW Test, Time, Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GGW Test, Time, Partial Thromboplastin

All 31
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K945940.
HemosIL Factor V Leiden (APC Resistance V)
K260551 · Instrumentation Laboratory (IL) Co. · Mar 2026
ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC
K851126 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
ACTIVAT-PARTIAL THROMBO-PLASTIN
K830320 · Helena Laboratories · Apr 1983
AB-TROL COAGULATION CONTROL
K802232 · Helena Laboratories · Nov 1980
HEP-TROL
K801932 · Helena Laboratories · Sep 1980
A-GENT QUANTICHROM THROMBIGEN I
K800725 · Abbott Laboratories · Jun 1980