Cleared Traditional

MICROTRAK(R) II CHLAMYDIA EIA ASSAY (K921462) - FDA 510(k) Clearance

Class I Microbiology device.

K921462 · Syva Co. · Microbiology device
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Sep 1992
Decision
182d
Days
Class 1
Risk

K921462 is an FDA 510(k) clearance for the MICROTRAK(R) II CHLAMYDIA EIA ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on September 25, 1992 after a review of 182 days - an extended review 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: 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 K921462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1992
Decision Date September 25, 1992
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 102d · This submission: 182d
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 K921462.
IMX SELECT CHLAMYDIA
K936054 · Abbott Laboratories · May 1996
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
K926090 · Syva Co. · Sep 1993
MICRO TRAK XL SYSTEM
K921747 · Syva Co. · Oct 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · Syva Co. · Mar 1991
SYVA MICROTRAK EIA ACCESSORY REAGENTS
K903758 · Syva Co. · Sep 1990