# K983922: Dried Gram-Negative and Gram-Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Jun 17, 1999 after 225 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 Cefdinir 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 Cefdinir. Organisms with indications for testing* include: Gram-Negative Bacteria: None** Gram-Positive Bacteria: Staphylococcus aureus*** (Including methicillin-susceptible, B-lactamase producing strains); Streptococcus pyogenes *As taken from the indications and Usage section of the manufacturer’s package insert (Issued: March 1998). **No gram-negative organisms for which Microscan is seeking clearance are indicated for testing in the Indications and Usage section of the manufacturer’s package insert. ***Cefdinir is inactive against methicillin-resistant Staphylococci. The following secondary organisms included for the testing of MicroScan® panels with Cefdinir have in vitro data but the safety and effectiveness in treating clinical infections have not been established: Citrobacter (diversus) koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Staphylococcus epidermidis (methicillin-susceptible), Streptococcus agalactiae The MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels with Cefdinir are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Source page: https://510kreport.com/device/K983922
Methodology: https://510kreport.com/methodology