# K043589: Microscan Dried Gram-Positive Mic/Combo Panels - Ertapenem

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Feb 14, 2005 after 48 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) MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels: named in the summary without a submission number

## Indications for use
The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35 0 C +/- I°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the addition of the antimicrobial Ertapenem at concentrations of 0.002 to 32 mcg/ml to the test panel. The gram-positive organisms which may be used for Ertapenem susceptibility testing in this panel are: Staphylococcus aureus (methicillin-susceptible strains) Streptococcus agalactiae

Source page: https://510kreport.com/device/K043589
Methodology: https://510kreport.com/methodology