Cleared Traditional

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (K914953) - FDA 510(k) Clearance

Class I Microbiology device.

K914953 · Stellar Bio Systems, Inc. · Microbiology device
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Feb 1992
Decision
106d
Days
Class 1
Risk

K914953 is an FDA 510(k) clearance for the IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY. Classified as Antisera, Fluorescent, Chlamydia Spp. (product code LKI), Class I - General Controls.

Submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on February 19, 1992 after a review of 106 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 Stellar Bio Systems, Inc. devices

Submission Details

510(k) Number K914953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date February 19, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 102d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKI Antisera, Fluorescent, Chlamydia Spp.
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.