# K042157: Daptomycin Antimicrobial Susceptibility Test Disc

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid, Ltd.
- Decided: Sep 14, 2004 after 35 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Antimicrobial Susceptibility Test Discs are for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. For Daptomycin these include Staphylococcus aureus including MRSA, Streptococcus agalactiae, Streptococcus disagalactiae subsp. equisimilis, Streptococcus pyogenes and Enterococcus faecalis (vancomycin-susceptible strains only).

Source page: https://510kreport.com/device/K042157
Methodology: https://510kreport.com/methodology