# K023202: Microscan Synergies Plus

- Pathway: 510(k) (Special)
- Applicant: Dade Microscan, Inc.
- Decided: Oct 23, 2002 after 28 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility for Gram-Negative organisms and screening for suspected ESBL production in E. coli, K. oxytoca and K. pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CQO, incubator, and read visually, according to the Package Insert. This particular submission is for the antimicrobials cefpodoxime (0.015-64 pg/ml) and ceftazidime (0.5-64 pg/mi). The Gram-Negative organisms which may be used for screening for suspected ESBL production in this panel are: Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

Source page: https://510kreport.com/device/K023202
Methodology: https://510kreport.com/methodology