# K091264: Microscan Dried Gram-Positive Mic/Combo Panels, Model B1017

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jul 22, 2009 after 83 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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. The FDA summary names its predicate without a number.
- (no number) MicroScan Dried Gram-Positive MIC/Combo Panels: named in the summary without a submission number

## Indications for use
The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. After inoculation, panels are incubated for 16 - 24 hours at 35°C +/- I°C in a non-CO 2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the evaluation of antimicrobial agent vancomycin on the MicroScan Dried Gram-Positive MIC/Combo Panels utilizing the updated Staphylococcus aureus interpretative criteria (S <_2, I=4-8, R> 16). The gram-positive organisms which may be used for vancomycin susceptibility testing in this panel are: Enterococcus spp. (e.g., Enterococcusfaecalis) Staphylococcus spp. (including Staphylococcus aureus) Staphylococcus epidermidis (including methicillin-resistant strains) Streptococcus agalactiae Streptococcus bovis

Source page: https://510kreport.com/device/K091264
Methodology: https://510kreport.com/methodology