Cleared Traditional

K854016 - ASSERACHROM PROTEIN C KIT

K854016 is an FDA 510(k) clearance for ASSERACHROM PROTEIN C KIT, manufactured by American Bioproducts Co.. The device is a Class 1 Hematology device with product code JLA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K854016 · American Bioproducts Co. · Hematology device
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Jan 1986
Decision
98d
Days
Class 1
Risk

K854016 is an FDA 510(k) clearance for the ASSERACHROM PROTEIN C KIT. Classified as Conversion To Creatinine, Creatine (product code JLA), Class I - General Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1210 - 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 - K854016

510(k) Number K854016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date January 03, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

JLA Device Classification - Class 1, General Controls

Product Code JLA Conversion To Creatinine, Creatine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1210
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.