Cleared Traditional

K961517 - ETEST SUBMISSION FOR CEFOTETAN

K961517 is the FDA 510(k) clearance for ETEST SUBMISSION FOR CEFOTETAN by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K961517 · Ab Biodisk · Microbiology device
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Jul 1996
Decision
74d
Days
Class 2
Risk

K961517 is an FDA 510(k) clearance for the ETEST SUBMISSION FOR CEFOTETAN. 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 July 5, 1996 after a review of 74 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 K961517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date July 05, 1996
Days to Decision 74 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
28d faster than avg
Panel avg: 102d · This submission: 74d
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 K961517.
ETEST FOR CEFEPIME
K963107 · Ab Biodisk · Oct 1996
ETEST SUBMISSION FOR AMOXICILLIN
K960991 · Ab Biodisk · Oct 1996
ETEST FOR AZTREONAM
K962794 · Ab Biodisk · Aug 1996
ETEST SUBMISSION FOR AZITHROMYCIN
K961519 · Ab Biodisk · Jul 1996
ETEST SUBMISSION FOR IMIPENEM
K960989 · Ab Biodisk · May 1996
ETEST SUBMISSION FOR VANCOMYCIN
K960990 · Ab Biodisk · May 1996