Cleared Traditional

ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT (K900402) - FDA 510(k) Clearance

Class I Microbiology device.

K900402 · Eastman Kodak Company · Microbiology device
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Mar 1990
Decision
38d
Days
Class 1
Risk

K900402 is an FDA 510(k) clearance for the ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 8, 1990 after a review of 38 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 Eastman Kodak Company devices

Submission Details

510(k) Number K900402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date March 08, 1990
Days to Decision 38 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
64d faster than avg
Panel avg: 102d · This submission: 38d
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 21
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K900402.
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758 · Syva Co. · Sep 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · Eastman Kodak Company · Jun 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · Abbott Laboratories · May 1990
KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
K895505 · Eastman Kodak Company · Jan 1990
ABBOTT TESTPACK CHLAMYDIA
K893676 · Abbott Laboratories · Jul 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · Abbott Laboratories · Jun 1989