Cleared Traditional

K853156 - ECHO TYPE 16 CF ANTIGEN

K853156 is an FDA 510(k) clearance for ECHO TYPE 16 CF ANTIGEN, manufactured by Hillcrest Biologicals. The device is a Class 1 Microbiology device with product code GNK cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K853156 · Hillcrest Biologicals · Microbiology device
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Nov 1985
Decision
100d
Days
Class 1
Risk

K853156 is an FDA 510(k) clearance for the ECHO TYPE 16 CF ANTIGEN. Classified as Antisera, Cf, Echovirus 1-34 (product code GNK), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3205 - 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

FDA 510(k) Submission Details - K853156

510(k) Number K853156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date November 07, 1985
Days to Decision 100 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 102d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

GNK Device Classification - Class 1, General Controls

Product Code GNK Antisera, Cf, Echovirus 1-34
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3205
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.