Cleared Traditional

IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT (K882674) - FDA 510(k) Clearance

Class I Microbiology device.

K882674 · Icn Immunobiologicals · Microbiology device
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Aug 1989
Decision
413d
Days
Class 1
Risk

K882674 is an FDA 510(k) clearance for the IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT. Classified as Antisera, Immunoperoxidase, Chlamydia Spp. (product code LKH), Class I - General Controls.

Submitted by Icn Immunobiologicals (Lisle, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Icn Immunobiologicals devices

Submission Details

510(k) Number K882674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1988
Decision Date August 15, 1989
Days to Decision 413 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 102d · This submission: 413d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKH Antisera, Immunoperoxidase, Chlamydia Spp.
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.