Cleared Traditional

K896032 - MODIFIED ELISA FOR CHLAMYDIA

K896032 is an FDA 510(k) clearance for MODIFIED ELISA FOR CHLAMYDIA, manufactured by Fairleigh Dickinson Laboratories, Inc.. The device is a Class 1 Chemistry device with product code LJC cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K896032 · Fairleigh Dickinson Laboratories, Inc. · Chemistry device
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Jan 1990
Decision
105d
Days
Class 1
Risk

K896032 is an FDA 510(k) clearance for the MODIFIED ELISA FOR CHLAMYDIA. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Fairleigh Dickinson Laboratories, Inc. (Abilene, US). The FDA issued a Cleared decision on January 29, 1990 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.3120 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Fairleigh Dickinson Laboratories, Inc. devices

FDA 510(k) Submission Details - K896032

510(k) Number K896032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date January 29, 1990
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
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 53
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K896032.
CHLAMYDIAZYME DIAGNOSTIC KIT
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ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
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CLEARVIEW CHLAMYDIA
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CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K895122 · Ciba Corning Diagnostics Corp. · Oct 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · Abbott Laboratories · Jul 1989