Cleared Traditional

K922003 - ANTIMICROBIAL SUSCETIBILITY TEST PANEL

K922003 is an FDA 510(k) clearance for ANTIMICROBIAL SUSCETIBILITY 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 112-day FDA review.

K922003 · Alamar Biosciences Laboratory, Inc. · Microbiology device
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Aug 1992
Decision
112d
Days
Class 2
Risk

K922003 is an FDA 510(k) clearance for the ANTIMICROBIAL SUSCETIBILITY 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 August 19, 1992 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alamar Biosciences Laboratory, Inc. devices

FDA 510(k) Submission Details - K922003

510(k) Number K922003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1992
Decision Date August 19, 1992
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
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 K922003.
ANTIMICROBIAL SUSCEPTIBILITY TEST
K924500 · Alamar Biosciences Laboratory, Inc. · Nov 1992
API UNISCEPT KB/TYPE 2 AND 3
K922926 · Analytical Products, Inc. · Oct 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922780 · 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 SUSCEPT. TEST PANEL NITROFURANTOIN
K911558 · Alamar Biosciences Laboratory, Inc. · May 1991