Cleared Traditional

K913459 - THE E TEST, MODIFICATION

K913459 is an FDA 510(k) clearance for THE E TEST, manufactured by Ab Biodisk. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K913459 · Ab Biodisk · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
51d
Days
Class 2
Risk

K913459 is an FDA 510(k) clearance for the THE E TEST, MODIFICATION. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk (Solna, SE). The FDA issued a Cleared decision on September 25, 1991 after a review of 51 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.

FDA 510(k) Submission Details - K913459

510(k) Number K913459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date September 25, 1991
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
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 440
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K913459.
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
K922003 · Alamar Biosciences Laboratory, Inc. · Aug 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922168 · Alamar Biosciences Laboratory, Inc. · Jul 1992
HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K912778 · Sensititre Microbiology A Div. of Radiometer · Feb 1992
API UNISCEPT KB
K912965 · Analytab Products, Inc. · Sep 1991
API UNISCEPT MIC/UNISCEPT MICRO-MIC
K912964 · Analytab Products, Inc. · Aug 1991
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
K912613 · Sensititre Microbiology A Div. of Radiometer · Aug 1991
K913459 · THE E TEST, MODIFICATION
Download PDF Ab Biodisk