Cleared Traditional

K971519 - ASSERACHROM TPA TEST KIT

K971519 is an FDA 510(k) clearance for ASSERACHROM TPA TEST KIT, manufactured by American Bioproducts Co.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K971519 · American Bioproducts Co. · Hematology device
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Aug 1997
Decision
116d
Days
Class 2
Risk

K971519 is an FDA 510(k) clearance for the ASSERACHROM TPA TEST KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on August 19, 1997 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 American Bioproducts Co. devices

FDA 510(k) Submission Details - K971519

510(k) Number K971519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date August 19, 1997
Days to Decision 116 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
3d slower than avg
Panel avg: 113d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 156
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K971519.
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K972482 · Reaads Medical Products, Inc. · Aug 1997
VON WILLEBRAND REAGENT
K972116 · Behring Diagnostics, Inc. · Jul 1997