Cleared Traditional

K941997 - BBL CRYSTAL MRSA ID SYSTEM

K941997 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 277-day FDA review.

K941997 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
277d
Days
Class 2
Risk

K941997 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 January 27, 1995 after a review of 277 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 - K941997

510(k) Number K941997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date January 27, 1995
Days to Decision 277 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 102d · This submission: 277d
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 K941997.
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · Baxter Diagnostics, Inc. · Feb 1995
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · Baxter Diagnostics, Inc. · Feb 1995
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · Baxter Diagnostics, Inc. · Jan 1995
PASCO MIC AND MIC/ID PANELS
K946126 · Pasco Laboratories, Inc. · Jan 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · Baxter Diagnostics, Inc. · Jan 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · Baxter Diagnostics, Inc. · Jan 1995