Cleared Traditional

K984581 - SYSTEM U3 FOR CEPHALOTHIN

K984581 is the FDA 510(k) clearance for SYSTEM U3 FOR CEPHALOTHIN by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K984581 · Ab Biodisk · Microbiology device
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Mar 1999
Decision
76d
Days
Class 2
Risk

K984581 is an FDA 510(k) clearance for the SYSTEM U3 FOR CEPHALOTHIN. 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 76 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

Submission Details

510(k) Number K984581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date March 09, 1999
Days to Decision 76 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
26d faster than avg
Panel avg: 102d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K984581.
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
K990685 · Ab Biodisk · Mar 1999
ETEST MINOCYCLINE
K990297 · Ab Biodisk · Mar 1999
SYSTEM U3 FOR CEFUROXIME
K984491 · Ab Biodisk · Mar 1999
SYSTEM U3
K983890 · Ab Biodisk · Feb 1999
SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID
K984144 · Ab Biodisk · Feb 1999
SYSTEM U3 FOR AMPICILLIN
K984087 · Ab Biodisk · Feb 1999