Cleared Traditional

K911558 - ANTIMICROBIAL SUSCEPT. TEST PANEL NITRO...

K911558 is an FDA 510(k) clearance for ANTIMICROBIAL SUSCEPT. TEST PANEL NITRO..., 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 37-day FDA review.

K911558 · Alamar Biosciences Laboratory, Inc. · Microbiology device
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May 1991
Decision
37d
Days
Class 2
Risk

K911558 is an FDA 510(k) clearance for the ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN. 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 May 15, 1991 after a review of 37 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 - K911558

510(k) Number K911558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date May 15, 1991
Days to Decision 37 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
65d faster than avg
Panel avg: 102d · This submission: 37d
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 K911558.
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
K922003 · Alamar Biosciences Laboratory, Inc. · Aug 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922168 · Alamar Biosciences Laboratory, Inc. · Jul 1992
THE E TEST, MODIFICATION
K913459 · Ab Biodisk · Sep 1991
ANTIMICROBIAL AMPICILLIN
K911185 · Alamar Biosciences Laboratory, Inc. · Apr 1991
ANTIMICROBIAL TOBRAMYCIN
K911304 · Alamar Biosciences Laboratory, Inc. · Apr 1991
ANTIMICROBIAL GENTAMICIN
K911305 · Alamar Biosciences Laboratory, Inc. · Apr 1991