Cleared Traditional

K921747 - MICRO TRAK XL SYSTEM

K921747 is the FDA 510(k) clearance for MICRO TRAK XL SYSTEM by Syva Co.. It is a Class 1 Microbiology device (product code LJC) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K921747 · Syva Co. · Microbiology device
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Oct 1992
Decision
171d
Days
Class 1
Risk

K921747 is an FDA 510(k) clearance for the MICRO TRAK XL SYSTEM. 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 October 1, 1992 after a review of 171 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 K921747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1992
Decision Date October 01, 1992
Days to Decision 171 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
69d slower than avg
Panel avg: 102d · This submission: 171d
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 43
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K921747.
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SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co. · Sep 1992
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
K921321 · Ortho Diagnostic Systems, Inc. · Aug 1992