Cleared Traditional

K912846 - JUSTONE(TM)

K912846 is an FDA 510(k) clearance for JUSTONE(TM), manufactured by Sensititre Microbiology A Div. of Radiometer. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K912846 · Sensititre Microbiology A Div. of Radiometer · Microbiology device
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Aug 1991
Decision
71d
Days
Class 2
Risk

K912846 is an FDA 510(k) clearance for the JUSTONE(TM). Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Sensititre Microbiology A Div. of Radiometer (Westlake, US). The FDA issued a Cleared decision on August 22, 1991 after a review of 71 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 Sensititre Microbiology A Div. of Radiometer devices

FDA 510(k) Submission Details - K912846

510(k) Number K912846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1991
Decision Date August 22, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 102d · This submission: 71d
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 K912846.
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
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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
ANTIMICROBIAL AMPICILLIN
K911185 · Alamar Biosciences Laboratory, Inc. · Apr 1991
ANTIMICROBIAL TOBRAMYCIN
K911304 · Alamar Biosciences Laboratory, Inc. · Apr 1991