Cleared Traditional

K900543 - CHLAMYDIAZYME DIAGNOSTIC KIT

K900543 is an FDA 510(k) clearance for CHLAMYDIAZYME DIAGNOSTIC KIT, 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 87-day FDA review.

K900543 · Abbott Laboratories · Microbiology device
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May 1990
Decision
87d
Days
Class 1
Risk

K900543 is an FDA 510(k) clearance for the CHLAMYDIAZYME DIAGNOSTIC KIT. 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 3, 1990 after a review of 87 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K900543

510(k) Number K900543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1990
Decision Date May 03, 1990
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
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 K900543.
QUIDEL CHLAMYDIA TEST
K901660 · Quidel Corp. · Jul 1990
PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
K902253 · Kallestad Diag, A Div. of Erbamont, Inc. · Jul 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · Eastman Kodak Company · Jun 1990
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
K900402 · Eastman Kodak Company · Mar 1990
CLEARVIEW CHLAMYDIA
K895280 · Unipath , Ltd. · Jan 1990
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505 · Eastman Kodak Company · Jan 1990