# K020160: Dried Gram-Positive Mic/Combo Panels with Ampicillin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 14, 2002 after 56 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- 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 MIC/Combo Panels: named in the summary without a submission number

## Recalls of this device
- May 4, 2018 · Class II · Z-2599-2018: The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

## 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 Gram-Positive cocci. 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 a revised QC range of > 0.5 mcg/ml for S. aureus ATCC #29213 with Ampicillin. The Gram-Positive organisms which may be used for Ampicillin susceptibility testing in this panel are: Staphylococcus aureus (beta-lactamase and non-beta-lactamase producing) Staphylococcus epidermidis (beta-lactamase and non-beta-lactamase producing) Staphyloccus saprophyticus (beta-lactamase and non-beta-lactamase producing) Streptococcus faecalis (Enterococcus) Streptococcus pyogenes The MicroScan® Dried Gram-Positive MIC/Combo Panels with Ampicillin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Source page: https://510kreport.com/device/K020160
Methodology: https://510kreport.com/methodology