Cleared Traditional

K910668 - ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MOD...

K910668 is the FDA 510(k) clearance for ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MOD... by Ortho Diagnostic Systems, Inc.. It is a Class 1 Microbiology device (product code LJC) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K910668 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Mar 1991
Decision
34d
Days
Class 1
Risk

K910668 is an FDA 510(k) clearance for the ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on March 19, 1991 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K910668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1991
Decision Date March 19, 1991
Days to Decision 34 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
68d faster than avg
Panel avg: 102d · This submission: 34d
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 K910668.
ANTIGENZ CHLAMYDIA
K912680 · Baxter Diagnostics, Inc. · Jul 1991
VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
K905787 · Vitek Systems, Inc. · Apr 1991
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K904189 · Ciba Corning Diagnostics Corp. · 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
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K903132 · Ortho Diagnostic Systems, Inc. · Dec 1990