Cleared Traditional

ASSERACHROM PROTEIN C KIT (K854016) - FDA 510(k) Clearance

Class I Hematology device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.