# K021181: Microscan Microstrep Plus Panel New Anticrobial-Clarithromycin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Jun 17, 2002 after 63 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The MicroScan@MICroSTREP pZusTM 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 Clarithromycin at concentrations of 0.015 to 2 mcg/d to the test panel The organisms which may be used for Clarithromycin susceptibility testing in this panel are: Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae Streptococci (Groups C, F, G) viridans group streptococci

Source page: https://510kreport.com/device/K021181
Methodology: https://510kreport.com/methodology