Cleared Traditional

K960235 - SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

K960235 is the FDA 510(k) clearance for SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES by Accumed Intl., Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K960235 · Accumed Intl., Inc. · Microbiology device
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Mar 1996
Decision
70d
Days
Class 2
Risk

K960235 is an FDA 510(k) clearance for the SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on March 27, 1996 after a review of 70 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 Accumed Intl., Inc. devices

Submission Details

510(k) Number K960235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1996
Decision Date March 27, 1996
Days to Decision 70 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
32d faster than avg
Panel avg: 102d · This submission: 70d
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 361
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K960235.
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
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K955910 · Dade Microscan, Inc. · Feb 1996
THE E TEST CEFTIZOXIME
K955920 · Ab Biodisk · Feb 1996
AMOXICILLIN/CLAVULANIC ACID 2/1
K954319 · Ab Biodisk · Dec 1995