Cleared Traditional

K052366 - ETEST TIGECYCLINE GRAM POSITIVE AND GRA...

K052366 is the FDA 510(k) clearance for ETEST TIGECYCLINE GRAM POSITIVE AND GRA... by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K052366 · Ab Biodisk · Microbiology device
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Oct 2005
Decision
45d
Days
Class 2
Risk

K052366 is an FDA 510(k) clearance for the ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCO.... 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 October 13, 2005 after a review of 45 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 Ab Biodisk devices

Submission Details

510(k) Number K052366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date October 13, 2005
Days to Decision 45 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
57d faster than avg
Panel avg: 102d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K052366.
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K060783 · Trek Diagnostic Systems, Inc. · May 2006
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · Trek Diagnostic Systems, Inc. · Sep 2005
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202 · Dade Behring, Inc. · Jun 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
K043589 · Dade Microscan, Inc. · Feb 2005