Cleared Traditional

K910484 - ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

K910484 is an FDA 510(k) clearance for ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL, manufactured by Alamar. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K910484 · Alamar · Microbiology device
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Mar 1991
Decision
33d
Days
Class 2
Risk

K910484 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 (Sacramento, US). The FDA issued a Cleared decision on March 11, 1991 after a review of 33 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 devices

FDA 510(k) Submission Details - K910484

510(k) Number K910484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1991
Decision Date March 11, 1991
Days to Decision 33 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 102d · This submission: 33d
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 392
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K910484.
ANTIMICROBIAL AMIKACIN
K911303 · Alamar Biosciences Laboratory, Inc. · Apr 1991
ANTIMICROBIAL AMPICILLIN/SULBACTAM
K911186 · Alamar Biosciences Laboratory, Inc. · Apr 1991
ANTIMICROBIAL CEFUROXIME
K911187 · Alamar Biosciences Laboratory, Inc. · Apr 1991
EF SYNERGY QUAD MODIFIED
K910242 · Remel Co. · Mar 1991
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS
K904689 · Alamar Biosciences Laboratory, Inc. · Feb 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K905853 · Alamar Biosciences Laboratory, Inc. · Feb 1991