Cleared Traditional

K021582 - BACTEC MGIT 960 PZA KIT

K021582 is an FDA 510(k) clearance for BACTEC MGIT 960 PZA KIT, manufactured by Becton, Dickinson & CO. The device is a Class 2 Microbiology device with product code MJA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K021582 · Becton, Dickinson & CO · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
60d
Days
Class 2
Risk

K021582 is an FDA 510(k) clearance for the BACTEC MGIT 960 PZA KIT. Classified as Susceptibility Test Powders, Antimycobacterial (product code MJA), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on July 13, 2002 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K021582

510(k) Number K021582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2002
Decision Date July 13, 2002
Days to Decision 60 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
42d faster than avg
Panel avg: 102d · This submission: 60d
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 K021582.
VERSATREK MYCO PZA KIT
K052323 · Trek Diagnostic Systems, Inc. · Jan 2006
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