Cleared Traditional

COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 (K853279) - FDA 510(k) Clearance

Class I Microbiology device.

K853279 · Hillcrest Biologicals · Microbiology device
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Nov 1985
Decision
94d
Days
Class 1
Risk

K853279 is an FDA 510(k) clearance for the COXSACKIE A2 CF ANTIGEN, A4, A10 & A16. Classified as Antisera, Cf, Coxsackievirus A 1-24, B 1-6 (product code GNO), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3145 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hillcrest Biologicals devices

Submission Details

510(k) Number K853279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date November 07, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNO Antisera, Cf, Coxsackievirus A 1-24, B 1-6
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3145
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.