Cleared Traditional

K912778 - HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE

K912778 is an FDA 510(k) clearance for HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE, 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 239-day FDA review.

K912778 · Sensititre Microbiology A Div. of Radiometer · Microbiology device
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Feb 1992
Decision
239d
Days
Class 2
Risk

K912778 is an FDA 510(k) clearance for the HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE. 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 February 18, 1992 after a review of 239 days - an extended review 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: 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 Sensititre Microbiology A Div. of Radiometer devices

FDA 510(k) Submission Details - K912778

510(k) Number K912778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date February 18, 1992
Days to Decision 239 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
137d slower than avg
Panel avg: 102d · This submission: 239d
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 K912778.
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922780 · Alamar Biosciences Laboratory, Inc. · Aug 1992
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 SUSCEPT. TEST PANEL NITROFURANTOIN
K911558 · Alamar Biosciences Laboratory, Inc. · May 1991
ANTIMICROBIAL AMPICILLIN
K911185 · Alamar Biosciences Laboratory, Inc. · Apr 1991