Cleared Traditional

K853277 - CMV CF ANTIGEN

K853277 is an FDA 510(k) clearance for CMV CF ANTIGEN, manufactured by Hillcrest Biologicals. The device is a Class 2 Microbiology device with product code GQI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K853277 · Hillcrest Biologicals · Microbiology device
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Nov 1985
Decision
94d
Days
Class 2
Risk

K853277 is an FDA 510(k) clearance for the CMV CF ANTIGEN. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special 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 866.3175 - 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 - K853277

510(k) Number K853277 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQI Device Classification - Class 2, Special Controls

Product Code GQI Antiserum, Cf, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.