Cleared Traditional

K984491 - SYSTEM U3 FOR CEFUROXIME

K984491 is an FDA 510(k) clearance for SYSTEM U3 FOR CEFUROXIME, manufactured by Ab Biodisk. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K984491 · Ab Biodisk · Microbiology device
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Mar 1999
Decision
82d
Days
Class 2
Risk

K984491 is an FDA 510(k) clearance for the SYSTEM U3 FOR CEFUROXIME. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk (Solna, SE). The FDA issued a Cleared decision on March 9, 1999 after a review of 82 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 Ab Biodisk devices

FDA 510(k) Submission Details - K984491

510(k) Number K984491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1998
Decision Date March 09, 1999
Days to Decision 82 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
20d faster than avg
Panel avg: 102d · This submission: 82d
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 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K984491.
ETEST FOR CEFUROXIME
K990722 · Ab Biodisk · Apr 1999
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
K990685 · Ab Biodisk · Mar 1999
ETEST MINOCYCLINE
K990297 · Ab Biodisk · Mar 1999
SYSTEM U3 FOR CEPHALOTHIN
K984581 · Ab Biodisk · Mar 1999
SYSTEM U3
K983890 · Ab Biodisk · Feb 1999
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K984489 · Accumed Intl., Inc. · Feb 1999