Cleared Traditional

GENE-TRAK CAMPYLOBACTER ASSAY (K863270) - FDA 510(k) Clearance

Class I Microbiology device.

K863270 · Integrated Genetics · Microbiology device
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Aug 1987
Decision
371d
Days
Class 1
Risk

K863270 is an FDA 510(k) clearance for the GENE-TRAK CAMPYLOBACTER ASSAY. Classified as Dna-reagents, Campylobacter Spp. (product code LQO), Class I - General Controls.

Submitted by Integrated Genetics (Framingham, US). The FDA issued a Cleared decision on August 31, 1987 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - 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.

View all Integrated Genetics devices

Submission Details

510(k) Number K863270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date August 31, 1987
Days to Decision 371 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 102d · This submission: 371d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQO Dna-reagents, Campylobacter Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
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.