Cleared Traditional

K912468 - LIATEST PROTEIN S KIT

K912468 is the FDA 510(k) clearance for LIATEST PROTEIN S KIT by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K912468 · American Bioproducts Co. · Hematology device
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Oct 1991
Decision
120d
Days
Class 2
Risk

K912468 is an FDA 510(k) clearance for the LIATEST PROTEIN S KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 120 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

Submission Details

510(k) Number K912468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1991
Decision Date October 02, 1991
Days to Decision 120 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
7d slower than avg
Panel avg: 113d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 126
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K912468.
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K903468 · Baxter Healthcare Corp · Feb 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247 · Helena Laboratories · Jan 1991
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174 · Helena Laboratories · Mar 1990