# K974362: Pasco Mic and Mic/ID Panels

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Feb 12, 1998 after 85 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 no predicate by number.

## Indications for use
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms. This 510(k) notification is for the addition of Cefepime to Pasco panels at concentrations of 0.03 to 64 mcg/ml for use in determining the susceptibility of Enterobacter spp., E. coli, K. pneumoniae, P. mirabilis, P. aeruginosa and methicillin susceptible strains of S. aureus. Clinical testing of S. pneumoniae has not been performed with the Pasco system.

Source page: https://510kreport.com/device/K974362
Methodology: https://510kreport.com/methodology