# K983746: Microstrep Plus Panel

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Dec 9, 1999 after 412 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
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) NCCLS Frozen Reference Panels: named in the summary without a submission number

## Indications for use
The MicroScan® MICroSTREP plus™ Panel is used to determine antimicrobial susceptibility of aerobic non-enterococcal 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 AMOXICILLIN at concentrations of 0.008 — 16 mcg/ML to the test panel The organisms which may be used for AMOXICILLIN susceptibility testing in this panel are; Streptococcus pneumoniae

Source page: https://510kreport.com/device/K983746
Methodology: https://510kreport.com/methodology