Cleared Traditional

K905787 - VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG A...

K905787 is the FDA 510(k) clearance for VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG A... by Vitek Systems, Inc.. It is a Class 1 Microbiology device (product code LJC) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K905787 · Vitek Systems, Inc. · Microbiology device
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Apr 1991
Decision
123d
Days
Class 1
Risk

K905787 is an FDA 510(k) clearance for the VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Vitek Systems, Inc. (Rockland, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 123 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 Vitek Systems, Inc. devices

Submission Details

510(k) Number K905787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date April 29, 1991
Days to Decision 123 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
21d slower than avg
Panel avg: 102d · This submission: 123d
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 46
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K905787.
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
K921321 · Ortho Diagnostic Systems, Inc. · Aug 1992
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884 · Vitek Systems, Inc. · Mar 1992
ANTIGENZ CHLAMYDIA
K912680 · Baxter Diagnostics, Inc. · Jul 1991
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K904189 · Ciba Corning Diagnostics Corp. · Mar 1991
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
K910668 · Ortho Diagnostic Systems, Inc. · Mar 1991
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · Syva Co. · Mar 1991