# K061872: Microscan Microstrep Plus Panel

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 23, 2006 after 51 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
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®Panel: named in the summary without a submission number

## 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 35°C +/- i°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument. This particular submission is for the addition of instrument read capability of the antimicrobial Trimethoprim/Sulfamethoxazole, at concentrations of 0.06/1.15 to 8/152 mcg/ml on the MicroScan MICroSTREP plus®Panel. The organisms which may be used for Trimethoprimn Sulfamethoxazole susceptibility testing on this panel are: Streptococcus pneumoniae

Source page: https://510kreport.com/device/K061872
Methodology: https://510kreport.com/methodology