# K191964: BD Kiestra IdentifA

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Nov 3, 2021 after 834 days
- Product code: QQV (Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry)
- Device class: 2
- Regulation: 21 CFR 866.3378
- 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 DEN170081 (2018). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170081: MALDI Biotyper CA System, Bruker Daltonik GmbH (2018) Summary page 14.

## Most influential descendants
- K222563: BD Kiestra IdentifA (2023), 0 descendants of its own

## Indications for use
The BD Kiestra IdentifA module is an automated in vitro diagnostic specimen preparation system for use with the BD Kiestra Laboratory Automation Solution to prepare MALDI targets for the Bruker MALDI Biotyper CA System for the qualitative identification and differentiation of microorganisms using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) analysis of colonies grown on plated culture media from human specimens. The BD Kiestra IdentifA is indicated for use in the clinical laboratory with the BD Kiestra ReadA Compact and Bruker MALDI Biotyper CA System to aid in the diagnosis of bacterial and fungal infections.

Source page: https://510kreport.com/device/K191964
Methodology: https://510kreport.com/methodology