Cleared Traditional

PTT-LT TEST KIT (K941210) - FDA 510(k) Clearance

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

K941210 · American Bioproducts Co. · Hematology device
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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

Submission Details

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
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.

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 K941210.
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