# K042331: Pasco Mic and Mic/ID Panels

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Oct 7, 2004 after 38 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
Inclusion of Telithromycin Pasco MIC and MIC/ID panels are used for quantitatively measuring 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 the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Telithromycin has been shown to be active in vitro against most strains of microorganism listed below, as described in the FDA-approved package insert for this antimicrobic. Active In Vitro and in Clinical Infectious Against: Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin and erythromycin susceptible isolates only)

Source page: https://510kreport.com/device/K042331
Methodology: https://510kreport.com/methodology