Cleared Traditional

KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES) (K895505) - FDA 510(k) Clearance

Class I Microbiology device.

K895505 · Eastman Kodak Company · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
113d
Days
Class 1
Risk

K895505 is an FDA 510(k) clearance for the KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES). 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 January 2, 1990 after a review of 113 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 Eastman Kodak Company devices

Submission Details

510(k) Number K895505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date January 02, 1990
Days to Decision 113 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
11d slower than avg
Panel avg: 102d · This submission: 113d
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 K895505.
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · Eastman Kodak Company · Jun 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · Abbott Laboratories · May 1990
ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
K900402 · Eastman Kodak Company · Mar 1990
ABBOTT TESTPACK CHLAMYDIA
K893676 · Abbott Laboratories · Jul 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · Abbott Laboratories · Jun 1989
MICROTRAK CHLAMYDIA EIA
K890196 · Syva Co. · Mar 1989