# K031103: Pasco Mic and Mic/ID Panels (Ertapenem)

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Jun 12, 2003 after 66 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 BreakpoinVID 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 the antimicrobial Ertapenem at concentrations of 0.03 - 32 mcg/ml to Pasco Panels. Ertapenem 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 Staphylococcus aureus (methicillin-susceptible strains only) Aerobic Gram-negative microorganisms Escherichia coli Klebsiella pneumoniae Active In Vitro but their clinical significance is unknown Aerobic Gram-negative microorganisms Citrobacterfreundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca (excluding ESBL producing strains) Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens

Source page: https://510kreport.com/device/K031103
Methodology: https://510kreport.com/methodology