# K062585: Microscan Microstrep Plus Panel Azithromycin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 19, 2006 after 18 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)
- K021169: Microstrep Plus Panel, Azithromycin, 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 35°C +/- 1°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 Azithromycin, at concentrations of 0.12 to 4 mcg/ml on the MicroScan MICroSTREP plus®Panel. The organisms which may be used for Azithromycin susceptibility testing in this panel are: Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus agalactiae Streptococci (Groups C, F, G) viridans group streptococci

Source page: https://510kreport.com/device/K062585
Methodology: https://510kreport.com/methodology