Cleared Traditional

K922374 - Q FEVER IGM IFA TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K922374 · Hillcrest Biologicals · Microbiology device
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Oct 1992
Decision
154d
Days
Class 1
Risk

K922374 is an FDA 510(k) clearance for the Q FEVER IGM IFA TEST. Classified as Antiserum, Fluorescent, Q Fever (product code GPJ), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on October 21, 1992 after a review of 154 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3500 - 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 K922374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date October 21, 1992
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GPJ Antiserum, Fluorescent, Q Fever
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3500
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.