Cleared Traditional

K905787 - VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST

K905787 is an FDA 510(k) clearance for VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG A..., manufactured by Vitek Systems, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K905787

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.

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 52
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