Cleared Traditional

IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (K862607) - FDA 510(k) Clearance

Class I Microbiology device.

K862607 · Boots-Celltech Diagnostics, Inc. · Microbiology device
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Aug 1986
Decision
27d
Days
Class 1
Risk

K862607 is an FDA 510(k) clearance for the IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (Berkshire, England, GB). The FDA issued a Cleared decision on August 4, 1986 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Boots-Celltech Diagnostics, Inc. devices

Submission Details

510(k) Number K862607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1986
Decision Date August 04, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 62
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K862607.
ARX Liquid Amies Collection & Transport System
K222613 · Arx Sciences, Inc. · Mar 2024
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad · Nov 1988
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · Syva Co. · Oct 1984
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079 · Syva Co. · Sep 1983