# K982156: Pasco Mic and Mic/ID Panels/ Cefdinir

- Pathway: 510(k) (Traditional)
- Applicant: Pasco Laboratories, Inc.
- Decided: Jul 29, 1998 after 41 days
- Product code: JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3800
- 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 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 Cefdinir to Pasco panels at concentrations of 0.03 to 8 mcg/ml for use in determining the susceptibility of methicillin susceptible strains of S. aureus. Clinical testing of Streptococci spp. including S. preumoniae with Cefdinir has not been performed with the Pasco system.

Source page: https://510kreport.com/device/K982156
Methodology: https://510kreport.com/methodology