Cleared Traditional

K864539 - MODIFIED IMAGEN(TM) CHLAMYDIA TEST

K864539 is the FDA 510(k) clearance for MODIFIED IMAGEN(TM) CHLAMYDIA TEST by Boots-Celltech Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LJP) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K864539 · Boots-Celltech Diagnostics, Inc. · Microbiology device
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Mar 1987
Decision
113d
Days
Class 1
Risk

K864539 is an FDA 510(k) clearance for the MODIFIED IMAGEN(TM) CHLAMYDIA TEST. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (Berkshire, England, GB). The FDA issued a Cleared decision on March 12, 1987 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Boots-Celltech Diagnostics, Inc. devices

Submission Details

510(k) Number K864539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date March 12, 1987
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 102d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJP Antiserum, Fluorescent, Chlamydia Trachomatis
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 - LJP Antiserum, Fluorescent, Chlamydia Trachomatis

All 17
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K864539.
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · Ortho Diagnostic Systems, Inc. · Apr 1988
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
K880031 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903 · Syva Co. · Aug 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · Syva Co. · Feb 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1987
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · Kallestad Laboratories, Inc. · Dec 1986