# K983408: Dried Gram-Negative and Gram-Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: May 10, 1999 after 224 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 Trovafloxacin Reference Panels: named in the summary without a submission number

## Most influential descendants
- K993102: Dried Gram-Positive Mic/Combo Panels (1999), 0 descendants of its own

## Indications for use
To determine gram-negative and gram-positive bacterial susceptibility against the antimicrobial agent Trovafloxacin. Organisms with indications for testing* include: Gram-Negative Bacteria Gram-Positive Bacteria Escherichia coli Methicillin susceptible Klebsiella pneumoniae Staphylococcus aureus Proteus mirabilis Methicillin susceptible Pseudomonas aeruginosa Staphylococcus epidermidis Enterococcus faecalis Streptococcus agalactiae (Gp.B) Streptococcus pyogenes (Gp.A) * As taken from the Indications and Usage section of the manufacturer’s package insert (Issued: December 1997). The MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels with Trovafloxacin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Source page: https://510kreport.com/device/K983408
Methodology: https://510kreport.com/methodology