Cleared Traditional

K960366 - SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

K960366 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 LTT) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K960366 · Accumed Intl., Inc. · Microbiology device
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Apr 1996
Decision
75d
Days
Class 2
Risk

K960366 is an FDA 510(k) clearance for the SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on April 9, 1996 after a review of 75 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 K960366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date April 09, 1996
Days to Decision 75 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
27d faster than avg
Panel avg: 102d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
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 - LTT Panels, Test, Susceptibility, Antimicrobial

All 45
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K960366.
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K993102 · Dade Microscan, Inc. · Dec 1999
PASCO MIC AND MIC/ID PANELS
K973317 · Pasco Laboratories, Inc. · Nov 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799 · Dade Microscan, Inc. · Oct 1997
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · Baxter Diagnostics, Inc. · Apr 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K945235 · Baxter Diagnostics, Inc. · Mar 1995
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · Baxter Diagnostics, Inc. · Feb 1995