Cleared Traditional

K880469 - CHLAMYDIAZYME(TM)

K880469 is an FDA 510(k) clearance for CHLAMYDIAZYME(TM), manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K880469 · Abbott Laboratories · Microbiology device
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May 1988
Decision
110d
Days
Class 1
Risk

K880469 is an FDA 510(k) clearance for the CHLAMYDIAZYME(TM). Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 23, 1988 after a review of 110 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K880469

510(k) Number K880469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1988
Decision Date May 23, 1988
Days to Decision 110 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
8d slower than avg
Panel avg: 102d · This submission: 110d
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 K880469.
PHARMACIA CHLAMYDIA EIA
K882676 · Pharmacia, Inc. · Aug 1988
ABBOTT TESTPACK CHLAMYDIA
K880783 · Abbott Laboratories · Jul 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · Abbott Laboratories · Jul 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
K880824 · Kallestad Diag, A Div. of Erbamont, Inc. · Apr 1988
CHLAMYDIAZYME DIAGNOSTIC KIT
K864842 · Abbott Laboratories · Apr 1987
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT
K863490 · Ortho Diagnostic Systems, Inc. · Nov 1986