Cleared Traditional

K935519 - ETEST FOR AMPICILLIN/SULBACTAM 2/1

K935519 is an FDA 510(k) clearance for ETEST FOR AMPICILLIN/SULBACTAM 2/1, manufactured by Ab Biodisk North America, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K935519 · Ab Biodisk North America, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K935519

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.

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 K935519.
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
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DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · Baxter Diagnostics, Inc. · Nov 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL
K934323 · Baxter Diagnostics, Inc. · Oct 1994
PASCO MIC AND MIC/ID PANELS
K944517 · Pasco Laboratories, Inc. · Oct 1994
PASCO MIC PANELS/ GENT & STREP SYNERGY
K934380 · Pasco Laboratories, Inc. · Jan 1994