# K062927: Microscan Microstrep Plus Panel Ampicillin (0.013 - 16 MCG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 12, 2006 after 14 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: 2 (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 Panel: 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

## 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 Streptococcuspneumoniae. 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 Ampicillin, at concentrations of 0.03- 16 mcg/ml on the MicroScan MICroSTREP plus®Panel. The organisms which may be used for Ampicillin susceptibility testing on this panel are: Streptococcus spp. other than Streptococcus pneumoniae

Source page: https://510kreport.com/device/K062927
Methodology: https://510kreport.com/methodology