Cleared Traditional

FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST (K931557) - FDA 510(k) Clearance

Class I Microbiology device.

K931557 · Fuller Laboratories, Inc. · Microbiology device
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Mar 1994
Decision
346d
Days
Class 1
Risk

K931557 is an FDA 510(k) clearance for the FULLER LABORATORIES MYCOPLASM PNEUMONIA IFA-IGG TEST. Classified as Antisera, Fluorescent, All, Mycoplasma Spp. (product code GRZ), Class I - General Controls.

Submitted by Fuller Laboratories, Inc. (Fullerton, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3375 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K931557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date March 11, 1994
Days to Decision 346 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
244d slower than avg
Panel avg: 102d · This submission: 346d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GRZ Antisera, Fluorescent, All, Mycoplasma Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3375
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.