Cleared Traditional

K832077 - MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT

K832077 is the FDA 510(k) clearance for MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT by Syva Co.. It is a Class 1 Microbiology device (product code LJP) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K832077 · Syva Co. · Microbiology device
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Sep 1983
Decision
93d
Days
Class 1
Risk

K832077 is an FDA 510(k) clearance for the MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 93 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 K832077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1983
Decision Date September 29, 1983
Days to Decision 93 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
9d faster than avg
Panel avg: 102d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJP Antiserum, Fluorescent, Chlamydia Trachomatis
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 - LJP Antiserum, Fluorescent, Chlamydia Trachomatis

All 16
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K832077.
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · Ortho Diagnostic Systems, Inc. · Dec 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · Syva Co. · Sep 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
K842623 · Syva Co. · Aug 1984
MICRO TRAK CHLAMYDIA TRAC CONTROL SLID
K832078 · Syva Co. · Sep 1983
MICRO TRAK CHLAMYDIA TRACHOMATIS CULT
K823010 · Syva Co. · Dec 1982