# K031205: Pasco Mic and Mic/ID Panels

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Jun 13, 2003 after 58 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K033119: Pasco Mic and Mic/ID Panels (2003), 0 descendants of its own

## Indications for use
Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the BreakpointhD 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 5 10(k) notification is for the addition of the antimicrobial Linezolid at concentrations of 0.25 - 8 mcg/ml to Pasco Panels. Linezolid 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 Enterococcus faecium (vancomycin-resistantstrains only) Staphylococcus aureus (including methicillin-resistantstrains) Active In Vitro but their clinical significance is unknown Aerobic Gram-positive microorganisms Enterococcus faecalis (including vancomycin-resistant strains) Enterococcusfaecium (vancomycin-susceptible strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus

Source page: https://510kreport.com/device/K031205
Methodology: https://510kreport.com/methodology