# K081182: Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test - Inducible Clindamycin

- Pathway: 510(k) (Traditional)
- Applicant: Siemens
- Decided: Aug 8, 2008 after 105 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- 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 0C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. The MicroScan Inducible Clindamycin test is intended to detect inducible clindamycin resistance in staphylococci in a broth microdilution system. The lCd test applies to isolates that are erythromycin resistant or intermediate and clindamycin susceptible or intermediate. This particular submission is for the addition of the Inducible Clindamycin test, consisting of 4 mcg/ml of erythromycin and 0.5 mcg/mi of clindamycin, to the test panel. The gram-positive organisms which may be used for the Inducible Clindamycin test in this panel are: Staphylococcus spp

Source page: https://510kreport.com/device/K081182
Methodology: https://510kreport.com/methodology