Cleared Traditional

K921321 - ORTHO CHLAMYDIA ANTIGEN ELISA TEST

K921321 is an FDA 510(k) clearance for ORTHO CHLAMYDIA ANTIGEN ELISA TEST, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K921321 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 1992
Decision
148d
Days
Class 1
Risk

K921321 is an FDA 510(k) clearance for the ORTHO CHLAMYDIA ANTIGEN ELISA TEST. 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 August 11, 1992 after a review of 148 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K921321

510(k) Number K921321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date August 11, 1992
Days to Decision 148 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 102d · This submission: 148d
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 K921321.
MICRO TRAK XL SYSTEM
K921747 · Syva Co. · Oct 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co. · Sep 1992
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