Cleared Traditional

K915454 - CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT

K915454 is an FDA 510(k) clearance for CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTI..., manufactured by Medical Packaging Corp.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 125-day FDA review.

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

FDA 510(k) Submission Details - K915454

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.

LIO Device Classification - Class 1, General Controls

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 35
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K915454.
ZINC PVA
K931383 · Remel Co. · Jun 1993
PARA-PAK PLUS
K931770 · Meridian Diagnostics, Inc. · Jun 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · Proteins Intl., Inc. · Jan 1993
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · Medical Laboratory Automation Systems, Inc. · Jan 1991