Cleared Traditional

SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION (K905179) - FDA 510(k) Clearance

Class I Microbiology device.

K905179 · Syva Co. · Microbiology device
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Mar 1991
Decision
113d
Days
Class 1
Risk

K905179 is an FDA 510(k) clearance for the SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION. 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 12, 1991 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 Syva Co. devices

Submission Details

510(k) Number K905179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date March 12, 1991
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 66
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K905179.
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K936054 · Abbott Laboratories · May 1996
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K926090 · Syva Co. · Sep 1993
MICRO TRAK XL SYSTEM
K921747 · Syva Co. · Oct 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co. · Sep 1992
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758 · Syva Co. · Sep 1990