Cleared Traditional

ETEST FOR AMPICILLIN/SULBACTAM 2/1 (K935519) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935519 · Ab Biodisk North America, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
351d
Days
Class 2
Risk

K935519 is an FDA 510(k) clearance for the ETEST FOR AMPICILLIN/SULBACTAM 2/1. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk North America, Inc. (S-17136 Solna, Sweden, SE). The FDA issued a Cleared decision on November 4, 1994 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ab Biodisk North America, Inc. devices

Submission Details

510(k) Number K935519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date November 04, 1994
Days to Decision 351 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 102d · This submission: 351d
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 440
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K935519.
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
K260447 · Biom?rieux SA · Apr 2026
MTS Gepotidacin 0.016-256 µg/mL
K260696 · Liofilchem S. R. L. · Apr 2026
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
K252114 · Liofilchem S. R. L. · Oct 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
K252062 · Thermo Fisher Scientific · Sep 2025
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
K250575 · Thermo Fisher Scientific · Sep 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
K252014 · Thermo Fisher Scientific · Aug 2025