# K152346: MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 16, 2015 after 27 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
Longest line of descent: 3 generations back to K003619 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150039: MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL), Siemens Healthcare Diagnostics, Inc. (2015) Summary page 4.

## Indications for use
The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. After inoculation, panels are incubated for 16 – 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the addition of the reformulated antimicrobial Vancomycin at concentrations of 0.25 to 64 μg/ml to the test panel. The gram-positive organisms which may be used for Vancomycin susceptibility testing in this panel are: Enterococci (e.g., Enterococcus faecalis) Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains)

Source page: https://510kreport.com/device/K152346
Methodology: https://510kreport.com/methodology