# K043545: Microscan Dried Gram-Positive Mic/Combo Panels with Daptomycin (0.03 - 16 MCG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 17, 2005 after 56 days
- Product code: LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: 1 (0 Class I)
- 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 its predicate without a number.
- (no number) MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels: named in the summary without a submission number

## Recalls of this device
- Dec 2, 2020 · Class II · Z-0720-2021: Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a po

## 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 cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- i°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 antimicrobial Daptomycin at concentrations of 0.03 to 16 mcg/ml to the test panel. The gram-positive organisms which may be used for Daptomycin susceptibility testing in this panel are: Enterococcusfaecalis (vancomycin-susceptible and resistant strains) Enterococcusfaecium (including vancomycin-resistant strains) Staphylococcus aureus (including methicillin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococus haemolyticus Streptococcus agalactiae

Source page: https://510kreport.com/device/K043545
Methodology: https://510kreport.com/methodology