Cleared Traditional

K042392 - DAPTOMYCIN

K042392 is the FDA 510(k) clearance for DAPTOMYCIN by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K042392 · Ab Biodisk · Microbiology device
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Dec 2004
Decision
102d
Days
Class 2
Risk

K042392 is an FDA 510(k) clearance for the DAPTOMYCIN. 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 December 13, 2004 after a review of 102 days - within the typical 510(k) review window.

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 Ab Biodisk devices

Submission Details

510(k) Number K042392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2004
Decision Date December 13, 2004
Days to Decision 102 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
At panel average
Panel avg: 102d · This submission: 102d
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 K042392.
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
ETEST FOR GEMIFLOXACIN
K042390 · Ab Biodisk · Nov 2004
PASCO MIC AND MIC/ID PANELS
K042331 · Pasco Laboratories, Inc. · Oct 2004
PASCO MIC AND MIC/ID PANELS
K041776 · Pasco Laboratories, Inc. · Aug 2004