# K041776: Pasco Mic and Mic/ID Panels

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Aug 3, 2004 after 33 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 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 for use in testing Streptococcus pneumoniae and Streptococcus spp. other than Streptococcus pneumoniae. Telithromycin has been shown to be active in vitro against most strains of microorganisms 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 Streptococcus pneumoniac (including multi-drug resistant isolates (MDRSP)) Active In Vitro but their clinical significance is unknown: Aerobic gram-positive microorganisms Streptococcus pyogenes (erythromycin susceptible isolates only) Streptococci (Lancefield groups C and G) Viridans group streptococci

Source page: https://510kreport.com/device/K041776
Methodology: https://510kreport.com/methodology