# K003619: Dried Gram-Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Jan 9, 2001 after 48 days
- Product code: LTT (Panels, Test, Susceptibility, Antimicrobial)
- 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K123933: Microscan Dried Gram-Positive Mic/Combo Panels - Ceftaroline (2013), 3 descendants of its own
- K150039: MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (2015), 2 descendants of its own
- K250036: MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (2025), 0 descendants of its own
- K152346: MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) (2015), 0 descendants of its own
- K131275: Microscan Dried Gram-Postive Mic/Combo Panels (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K003619
Methodology: https://510kreport.com/methodology