Cleared Traditional

K922374 - Q FEVER IGM IFA TEST

K922374 is an FDA 510(k) clearance for Q FEVER IGM IFA TEST, manufactured by Hillcrest Biologicals. The device is a Class 1 Microbiology device with product code GPJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

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

FDA 510(k) Submission Details - K922374

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

GPJ Device Classification - Class 1, General Controls

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.