Cleared Traditional

K941210 - PTT-LT TEST KIT

K941210 is an FDA 510(k) clearance for PTT-LT TEST KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GGW cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K941210 · American Bioproducts Co. · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
372d
Days
Class 2
Risk

K941210 is an FDA 510(k) clearance for the PTT-LT TEST KIT. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K941210

510(k) Number K941210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 14, 1994
Decision Date March 21, 1995
Days to Decision 372 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
259d slower than avg
Panel avg: 113d · This submission: 372d
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 26
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K941210.
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
STACLOT(R) PNP TEST KIT
K924370 · American Bioproducts Co. · Aug 1993
PTT-LA TEST KIT
K921684 · American Bioproducts Co. · Jun 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
K915463 · Sigma Diagnostics, Inc. · Jan 1992