# K021037: Microstrep Plus Panel with Ampicillin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 6, 2002 after 35 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 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 Ampicillin at concentrations of 0.03 to 16 mcg/ml to the test panel The organisms which may be used for Ampicillin susceptibility testing in this panel are: Streptococcus spp. other than Streptococcus pneumoniae

Source page: https://510kreport.com/device/K021037
Methodology: https://510kreport.com/methodology