# K091949: Microscan Microstrep Plus, Model B1027-201

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jan 26, 2010 after 209 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 3 (0 Class I)
- 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® MICroSTREP plus®Panels: named in the summary without a submission number

## Recalls of this device
- Sep 10, 2015 · Class II · Z-0108-2016: Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results
- Sep 10, 2015 · Class II · Z-0109-2016: Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results
- Mar 6, 2013 · Class II · Z-1272-2013: Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.

## Indications for use
The MicroScano MICroSTREP pluso 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 +/- 1 C in a non-CO2 incubator, and read either visually or with MicroScan® WalkAway instrument. This particular submission is-for the evaluation of antimicrobial agent penicillin on the MicroScan® MIC~roSTREP plus® Panel utilizing the updated Streptococcuspneumoniae meningitis interpretative criteria (S <0006, R> 0. 12) and non-meningitis interpretative criteria (S <2, 1 =4 R Ž8). The organisms which may be used for Penicillin susceptibility testing in this panel are: Streptococcuspneumoniae Streptococci (Groups A, C, G, H, L and M) Streptococcus agalactiae Viridans Streptococci

Source page: https://510kreport.com/device/K091949
Methodology: https://510kreport.com/methodology