# K222563: BD Kiestra IdentifA

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Aug 31, 2023 after 372 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: 2 generations back to DEN170081 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191964: BD Kiestra IdentifA, Becton, Dickinson and Company (2021) Summary page 9.

## 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 System (CA, sirius CA, or sirius one CA) 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 or ReadA Compact and Bruker MALDI Biotyper System (CA, sirius CA, or sirius one CA) to aid in the diagnosis of bacterial and fungal infections.

Source page: https://510kreport.com/device/K222563
Methodology: https://510kreport.com/methodology