Cleared Traditional

VISIBLE-CHLAMYDIA(TM) TEST SYSTEM (K862638) - FDA 510(k) Clearance

Class I Microbiology device.

K862638 · Isolab, Inc. · Microbiology device
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Aug 1986
Decision
47d
Days
Class 1
Risk

K862638 is an FDA 510(k) clearance for the VISIBLE-CHLAMYDIA(TM) TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on August 26, 1986 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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: 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 Isolab, Inc. devices

Submission Details

510(k) Number K862638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1986
Decision Date August 26, 1986
Days to Decision 47 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 102d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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.

Regulatory Peers - LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

All 66
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K862638.
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SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co. · Sep 1992