# K993102: Dried Gram-Positive Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Dec 2, 1999 after 77 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
Longest line of descent: 1 generation back to K983408 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983408: Dried Gram-Negative and Gram-Positive Mic/Combo Panels, Dade Microscan, Inc. (1999) Summary page 1.

## Indications for use
To determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid. Organisms with indications for testing include: FROM THE INDICATION FOR USE SECTION OF THE MANUFACTURER’S PACKAGE INSERT (7-14-99) Methicillin-susceptible Staphylococcus aureus Vancomycin resistant Enterococcus faecium Streptococcus pyogenes (Gp.A) FROM THE MICROBIOLOGY SECTION OF THE MANUFACTURER’S PACKAGE INSERT (7-14-99). Streptococcus agalactiae (Gp.B) Methicillin-resistant Staphylococcus aureus Staphylococcus epidermidis The MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid are not intended for use with SiFeptococcus pneumoniae and viridans streptococcl.

Source page: https://510kreport.com/device/K993102
Methodology: https://510kreport.com/methodology