Cleared Traditional

CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT (K915454) - FDA 510(k) Clearance

Class I Microbiology device.

K915454 · Medical Packaging Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
125d
Days
Class 1
Risk

K915454 is an FDA 510(k) clearance for the CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Medical Packaging Corp. (Bethesda, US). The FDA issued a Cleared decision on April 8, 1992 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Medical Packaging Corp. devices

Submission Details

510(k) Number K915454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1991
Decision Date April 08, 1992
Days to Decision 125 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 102d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - LIO Device, Specimen Collection

All 62
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K915454.
ARX Liquid Amies Collection & Transport System
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PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad · Nov 1988
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987
MODIFICATION MICROTRAK DIRECT SPECIMEN TEST
K843935 · Syva Co. · Oct 1984
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079 · Syva Co. · Sep 1983