Cleared Traditional

K926294 - BBL CRYSTAL MRSA ID SYSTEM

K926294 is an FDA 510(k) clearance for BBL CRYSTAL MRSA ID SYSTEM, manufactured by Becton Dickinson Microbiology Systems. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K926294 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
155d
Days
Class 2
Risk

K926294 is an FDA 510(k) clearance for the BBL CRYSTAL MRSA ID SYSTEM. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on May 18, 1993 after a review of 155 days - an extended review 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: 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 Becton Dickinson Microbiology Systems devices

FDA 510(k) Submission Details - K926294

510(k) Number K926294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date May 18, 1993
Days to Decision 155 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
53d slower than avg
Panel avg: 102d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 405
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K926294.
PASCO MIC AND MIC/ID PANELS
K932917 · Pasco Laboratories, Inc. · Aug 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K932082 · Baxter Diagnostics, Inc. · Jul 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930469 · Alamar Biosciences Laboratory, Inc. · Jun 1993
PASCO MIC AND MIC/ID PANELS
K931069 · Pasco Laboratories, Inc. · May 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930055 · Alamar Biosciences Laboratory, Inc. · Apr 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K926545 · Baxter Diagnostics, Inc. · Mar 1993