Cleared Traditional

K941210 - PTT-LT TEST KIT

K941210 is the FDA 510(k) clearance for PTT-LT TEST KIT by American Bioproducts Co.. It is a Class 2 Hematology device (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

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
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.

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 20
Devices cleared under the same product code (GGW) and FDA review panel - the closest regulatory comparables to K941210.
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