# K980955: Pasco Mic and Mic/ID Panels

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: May 18, 1998 after 66 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- 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 gqualitative 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 Trovafloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for use in determining the susceptibility of C. freundii, E. aerogenes, E. coli, K. pneumoniae, Morganella morganii, P. mirabilis, P. vulgaris, P. aeruginosa, E- faecalis and methicillin susceptible strains of S. aureus and S. epidermidis. Clinical testing of S. pneumoniae with Trovafloxacin has not been performed with the Pasco system.

Source page: https://510kreport.com/device/K980955
Methodology: https://510kreport.com/methodology