# K130831: Maldi Biotyper CA (MBT-CA) System

- Pathway: 510(k) (Traditional)
- Applicant: Bruker Daltonics, Inc.
- Decided: Nov 21, 2013 after 240 days
- Product code: PEX (System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates)
- Device class: 2
- Regulation: 21 CFR 866.3361
- 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 DEN130013 (2013). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130013: Vitek MS, bioMerieux, Inc. (2013). Our reading of the summary gave K124067, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130013, Vitek MS (bioMerieux, Inc.), granted Aug 21, 2013; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K142677: MALDI Biotyper CA System (2015), 1 descendant of its own
- K163536: MALDI Biotyper CA (MBT-CA) System, MBT smart CA System (2017), 0 descendants of its own

## Indications for use
The MALDI Biotyper CA System is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections.

Source page: https://510kreport.com/device/K130831
Methodology: https://510kreport.com/methodology