Cleared Traditional

K924370 - STACLOT(R) PNP TEST KIT

K924370 is an FDA 510(k) clearance for STACLOT PNP 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 346-day FDA review.

K924370 · American Bioproducts Co. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
346d
Days
Class 2
Risk

K924370 is an FDA 510(k) clearance for the STACLOT(R) PNP TEST KIT. Classified as Test, Time, Partial Thromboplastin (product code GGW), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 346 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 - K924370

510(k) Number K924370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1992
Decision Date August 09, 1993
Days to Decision 346 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 113d · This submission: 346d
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 K924370.
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
PTT-LA TEST KIT
K921684 · American Bioproducts Co. · Jun 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
K915463 · Sigma Diagnostics, Inc. · Jan 1992
READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT
K902236 · Biosearch Medical Products, Inc. · Aug 1990