Cleared Traditional

K965190 - SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PN...

K965190 is the FDA 510(k) clearance for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PN... by Accumed Intl., Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K965190 · Accumed Intl., Inc. · Microbiology device
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Mar 1997
Decision
85d
Days
Class 2
Risk

K965190 is an FDA 510(k) clearance for the SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE. 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 19, 1997 after a review of 85 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 K965190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date March 19, 1997
Days to Decision 85 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
17d faster than avg
Panel avg: 102d · This submission: 85d
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 K965190.
AMIKACIN
K970210 · Ab Biodisk · May 1997
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
K970473 · Ab Biodisk · May 1997
ETEST SPARFLOXACIN
K970820 · Ab Biodisk · Apr 1997
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