Cleared Traditional

K945940 - COATEST(R) APC(TM) RESISTANCE

K945940 is an FDA 510(k) clearance for COATEST APC(TM) RESISTANCE, manufactured by Axis-Shield Doc AS. The device is a Class 2 Hematology device with product code GGW cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K945940 · Axis-Shield Doc AS · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Axis-Shield Doc AS devices

FDA 510(k) Submission Details - K945940

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.

GGW Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K945940.
GRADILEIDEN V TEST
K992456 · Gradipore , Ltd. · Dec 1999
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
K982062 · Precision Biologicals, Inc. · Jan 1999
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
K963111 · Chromogenix AB · Dec 1996
PTT-LT TEST KIT
K941210 · American Bioproducts Co. · Mar 1995
STACLOT(R) PNP TEST KIT
K924370 · American Bioproducts Co. · Aug 1993
PTT-LA TEST KIT
K921684 · American Bioproducts Co. · Jun 1992