Cleared Traditional

K863270 - GENE-TRAK CAMPYLOBACTER ASSAY

K863270 is an FDA 510(k) clearance for GENE-TRAK CAMPYLOBACTER ASSAY, manufactured by Integrated Genetics. The device is a Class 1 Microbiology device with product code LQO cleared through the Traditional 510(k) pathway after a 371-day FDA review.

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

FDA 510(k) Submission Details - K863270

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.

LQO Device Classification - Class 1, General Controls

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.