Cleared Traditional

K060621 - SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM...

K060621 is an FDA 510(k) clearance for SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM..., manufactured by Tds Holdings, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K060621 · Tds Holdings, Inc. · Microbiology device
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Apr 2006
Decision
44d
Days
Class 2
Risk

K060621 is an FDA 510(k) clearance for the SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUS.... Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Tds Holdings, Inc. (Cleveland, US). The FDA issued a Cleared decision on April 21, 2006 after a review of 44 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 Tds Holdings, Inc. devices

FDA 510(k) Submission Details - K060621

510(k) Number K060621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2006
Decision Date April 21, 2006
Days to Decision 44 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
58d faster than avg
Panel avg: 102d · This submission: 44d
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 K060621.
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687 · Dade Behring, Inc. · Jul 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536 · Dade Behring, Inc. · Jul 2006
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
K060783 · Trek Diagnostic Systems, Inc. · May 2006
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
K052366 · Ab Biodisk · Oct 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · Trek Diagnostic Systems, Inc. · Sep 2005
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202 · Dade Behring, Inc. · Jun 2005