Cleared Traditional

K960991 - ETEST SUBMISSION FOR AMOXICILLIN

K960991 is the FDA 510(k) clearance for ETEST SUBMISSION FOR AMOXICILLIN by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K960991 · Ab Biodisk · Microbiology device
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Oct 1996
Decision
211d
Days
Class 2
Risk

K960991 is an FDA 510(k) clearance for the ETEST SUBMISSION FOR AMOXICILLIN. 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 October 8, 1996 after a review of 211 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 Ab Biodisk devices

Submission Details

510(k) Number K960991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date October 08, 1996
Days to Decision 211 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
109d slower than avg
Panel avg: 102d · This submission: 211d
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 K960991.
STREPTOCOCCUS MIC PANEL
K963641 · Dade Microscan, Inc. · Dec 1996
PIPERACILLIN/TAZOBACTAM 4
K964203 · Ab Biodisk · Dec 1996
ETEST FOR CEFEPIME
K963107 · Ab Biodisk · Oct 1996
ETEST FOR AZTREONAM
K962794 · Ab Biodisk · Aug 1996
ETEST SUBMISSION FOR CEFOTETAN
K961517 · Ab Biodisk · Jul 1996
ETEST SUBMISSION FOR AZITHROMYCIN
K961519 · Ab Biodisk · Jul 1996