# K020556: Microscan Microstrep Plus Panel with Levofloxacin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Apr 26, 2002 after 65 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test 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: 1 generation back to K963641 (1996). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963641: Streptococcus Mic Panel, Dade Microscan, Inc. (1996) Summary page 1.

## Most influential descendants
- K111677: Microscan (R) Microstrep Plus (R) (2011), 0 descendants of its own
- K111205: Microscan (R) Microstrep Plus (R) Panels (2011), 0 descendants of its own
- K111394: Microscan Microstep (2011), 0 descendants of its own
- K062276: Microscan Microstrep Plus Panel (2006), 0 descendants of its own

## 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. This particular submission is for the addition of the antimicrobial Levofloxacin at concentrations of 0.12 to 16 mcg/ml to the test panel The organisms which may be used for Levofloxacin susceptibility testing in this panel are; Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus (Group C/F) Streptococcus (Group G) Streptococcus agalactiae Viridans group streptococci

Source page: https://510kreport.com/device/K020556
Methodology: https://510kreport.com/methodology