Cleared Traditional

K914953 - IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY

K914953 is an FDA 510(k) clearance for IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY, manufactured by Stellar Bio Systems, Inc.. The device is a Class 1 Microbiology device with product code LKI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K914953

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.

LKI Device Classification - Class 1, General Controls

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.