Cleared Traditional

K904689 - ANTIMICROBIAL SUSCEPT TEST PANEL/ADD AN...

K904689 is an FDA 510(k) clearance for ANTIMICROBIAL SUSCEPT TEST PANEL/ADD AN..., 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 120-day FDA review.

K904689 · Alamar Biosciences Laboratory, Inc. · Microbiology device
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Feb 1991
Decision
120d
Days
Class 2
Risk

K904689 is an FDA 510(k) clearance for the ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS. 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 February 7, 1991 after a review of 120 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 - K904689

510(k) Number K904689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1990
Decision Date February 07, 1991
Days to Decision 120 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
18d slower than avg
Panel avg: 102d · This submission: 120d
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 K904689.
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 SUSCEPTIBILITY TEST PANEL
K905853 · Alamar Biosciences Laboratory, Inc. · Feb 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
K904523 · Alamar Biosciences Laboratory, Inc. · Dec 1990
EF SYNERGY QUAD
K903589 · Remel Co. · Nov 1990