Cleared Traditional

K890196 - MICROTRAK CHLAMYDIA EIA

K890196 is the FDA 510(k) clearance for MICROTRAK CHLAMYDIA EIA by Syva Co.. It is a Class 1 Microbiology device (product code LJC) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K890196 · Syva Co. · Microbiology device
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Mar 1989
Decision
63d
Days
Class 1
Risk

K890196 is an FDA 510(k) clearance for the MICROTRAK CHLAMYDIA EIA. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 63 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 Syva Co. devices

Submission Details

510(k) Number K890196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date March 22, 1989
Days to Decision 63 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
39d faster than avg
Panel avg: 102d · This submission: 63d
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 46
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K890196.
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K895122 · Ciba Corning Diagnostics Corp. · Oct 1989
ABBOTT TESTPACK CHLAMYDIA
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CHLAMYDIAZYME BLOCKING REAGENT
K892371 · Abbott Laboratories · Jun 1989
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · Abbott Laboratories · Dec 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · Kallestad Diag, A Div. of Erbamont, Inc. · Nov 1988
KODAK SURECELL CHLAMYDIA TEST KIT
K882923 · Eastman Kodak Company · Nov 1988