# K111205: Microscan (R) Microstrep Plus (R) Panels

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 20, 2011 after 82 days
- Product code: LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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
Longest line of descent: 2 generations back to K963641 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020556: Microscan Microstrep Plus Panel with Levofloxacin, Dade Microscan, Inc. (2002) Summary page 1.

## Indications for use
The MicroScan® MICroSTREP plus" Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 -24 hours at 350 C +/- 1VC in a non-C02 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package Insert. This particular submission is for the addition of the antimicrobial Moxifloxacin at concentrations of 0.03 to 8 pg/mI to the test panel. The organisms which may be used for Moxifloxacin susceptibility testing in this panel are: Streptococcus pneunioniae (including penicillin resistant strains) Streptococcus pyo genes Streptoccocus agalecie Streptococcus constellatus Streptococcus anginosus Viridans group streptococci

Source page: https://510kreport.com/device/K111205
Methodology: https://510kreport.com/methodology