Cleared Traditional

K904189 - CIBA CORNING MAGIC LITE CHLAMYDIA IMMUN...

K904189 is an FDA 510(k) clearance for CIBA CORNING MAGIC LITE CHLAMYDIA IMMUN..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K904189 · Ciba Corning Diagnostics Corp. · Microbiology device
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Mar 1991
Decision
196d
Days
Class 1
Risk

K904189 is an FDA 510(k) clearance for the CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on March 27, 1991 after a review of 196 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K904189

510(k) Number K904189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date March 27, 1991
Days to Decision 196 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
94d slower than avg
Panel avg: 102d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

LJC Device Classification - Class 1, General Controls

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 46
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K904189.
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884 · Vitek Systems, Inc. · Mar 1992
ANTIGENZ CHLAMYDIA
K912680 · Baxter Diagnostics, Inc. · Jul 1991
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
K905787 · Vitek Systems, Inc. · Apr 1991
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
K910668 · Ortho Diagnostic Systems, Inc. · Mar 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · Syva Co. · Mar 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725 · Kallestad Diag, A Div. of Erbamont, Inc. · Jan 1991