Cleared Traditional

K896965 - ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

K896965 is an FDA 510(k) clearance for ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL, manufactured by Alamar Biosciences Laboratory, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K896965 · Alamar Biosciences Laboratory, Inc. · Microbiology device
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Jan 1990
Decision
45d
Days
Class 2
Risk

K896965 is an FDA 510(k) clearance for the ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Alamar Biosciences Laboratory, Inc. (Sacramento, US). The FDA issued a Cleared decision on January 29, 1990 after a review of 45 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 Alamar Biosciences Laboratory, Inc. devices

FDA 510(k) Submission Details - K896965

510(k) Number K896965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1989
Decision Date January 29, 1990
Days to Decision 45 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 102d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

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 391
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K896965.
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
K896566 · Medical Specialties, Inc. · Feb 1990
PASCO MIC/ID GRAM-POSITIVE PANEL
K895215 · Difco Laboratories, Inc. · Jan 1990
API UNISCEPT KB
K895796 · Analytical Products, Inc. · Nov 1989
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K894514 · Alamar Biosciences Laboratory, Inc. · Nov 1989
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1989