Cleared Traditional

K052323 - VERSATREK MYCO PZA KIT

K052323 is an FDA 510(k) clearance for VERSATREK MYCO PZA KIT, manufactured by Trek Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code MJA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K052323 · Trek Diagnostic Systems, Inc. · Microbiology device
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Jan 2006
Decision
147d
Days
Class 2
Risk

K052323 is an FDA 510(k) clearance for the VERSATREK MYCO PZA KIT. Classified as Susceptibility Test Powders, Antimycobacterial (product code MJA), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Sun Prairie, US). The FDA issued a Cleared decision on January 19, 2006 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Trek Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K052323

510(k) Number K052323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2005
Decision Date January 19, 2006
Days to Decision 147 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 102d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJA Device Classification - Class 2, Special Controls

Product Code MJA Susceptibility Test Powders, Antimycobacterial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - MJA Susceptibility Test Powders, Antimycobacterial

Devices cleared under the same product code (MJA) and FDA review panel - the closest regulatory comparables to K052323.
BACTEC MGIT 960 PZA KIT
K021582 · Becton, Dickinson & CO · Jul 2002
BACTEC MGIT 960 SIRE KITS
K014123 · Becton, Dickinson & CO · Apr 2002
BACTEC MGIT 960 SIR KITS
K003062 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 2001
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
K972772 · Trek Diagnostic Systems, Inc. · Jul 1999