Cleared Traditional

K862607 - IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

K862607 is an FDA 510(k) clearance for IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTIO..., manufactured by Boots-Celltech Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 27-day FDA review.

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.

FDA 510(k) Submission Details - K862607

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

LIO Device Classification - Class 1, General Controls

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.
MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
K870963 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1987
KULTSURE
K870231 · Ncs Diagnostics, Inc. · Feb 1987
CULT-UR
K864727 · R.P. Laboratories, Inc. · Jan 1987
KULTSURE (CATALOGUE NO. M200)
K860655 · Ncs Diagnostics, Inc. · Mar 1986
LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)
K854719 · Xsirius Scientific, Inc. · Feb 1986
VIRTRAN VIRAL TRANPORTER
K851378 · Diagnon Corp. · Jun 1985
K862607 · IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
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