Cleared Traditional

K832132 - SERA-TEK MYCOPLASMA ANTIBODY TEST (FDA 510(k) Clearance)

Class I Immunology device.

K832132 · Miles Laboratories, Inc. · Immunology device
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Sep 1983
Decision
81d
Days
Class 1
Risk

K832132 is an FDA 510(k) clearance for the SERA-TEK MYCOPLASMA ANTIBODY TEST. Classified as Antigens, Cf, All, Mycoplasma Spp. (product code GSB), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3375 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Miles Laboratories, Inc. devices

Submission Details

510(k) Number K832132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1983
Decision Date September 20, 1983
Days to Decision 81 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 104d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GSB Antigens, Cf, 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.