Cleared Traditional

K880799 - MODIFIED IDEIA CHLAMYDIA TEST

K880799 is the FDA 510(k) clearance for MODIFIED IDEIA CHLAMYDIA TEST by Boots-Celltech Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LJC) cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K880799 · Boots-Celltech Diagnostics, Inc. · Microbiology device
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Dec 1988
Decision
283d
Days
Class 1
Risk

K880799 is an FDA 510(k) clearance for the MODIFIED IDEIA CHLAMYDIA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on December 8, 1988 after a review of 283 days - an extended review 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: 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 K880799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1988
Decision Date December 08, 1988
Days to Decision 283 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 102d · This submission: 283d
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 47
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K880799.
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · Abbott Laboratories · Jun 1989
MICROTRAK CHLAMYDIA EIA
K890196 · Syva Co. · Mar 1989
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · Abbott Laboratories · Dec 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · Kallestad Diag, A Div. of Erbamont, Inc. · Nov 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · Eastman Kodak Company · Nov 1988
PHARMACIA CHLAMYDIA EIA
K882676 · Pharmacia, Inc. · Aug 1988