Cleared Traditional

K850003 - COXSACKIE B SERIES CF ANTIGENS (FDA 510(k) Clearance)

Class I Microbiology device.

K850003 · Hillcrest Biologicals · Microbiology device
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Mar 1985
Decision
62d
Days
Class 1
Risk

K850003 is an FDA 510(k) clearance for the COXSACKIE B SERIES CF ANTIGENS. Classified as Antigens, Cf (including Cf Control), Coxsackievirus A 1-24, B 1-6 (product code GNG), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hillcrest Biologicals devices

Submission Details

510(k) Number K850003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1985
Decision Date March 05, 1985
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 102d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNG Antigens, Cf (including Cf Control), 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.