# K983711: Dried Gram-Negative and Gram-Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Apr 27, 1999 after 188 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 Grepafloxacin Reference Panels: named in the summary without a submission number

## Indications for use
To determine gram-negative and gram-positive bacterial susceptibility against the antimicrobial agent Grepafloxacin. There are no organisms for which MicroScan® panels are intended for testing, that are included in the ‘Indications and Usage’ as stated in the FDA approval of Grepafloxacin. The following secondary organisms included for the testing of MicroScan® panels have in vitro data but the safety and effectiveness in treating clinical infections have not been established: Citrobacter freundii, Citrobacter (diversus) koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin-susceptible), Streptococcus agalactiae, Streptococcus pyogenes. The MicroScan® Dried Gram-Positive MIC/Combo Panels with Grepafloxacin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Source page: https://510kreport.com/device/K983711
Methodology: https://510kreport.com/methodology