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BD Kiestra IdentifA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191964

by Becton, Dickinson and Company

Identifiers

510(k) Number
K191964 FDA 510(k)
FDA Product Code
QQV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3378 FDA 510(k)
Regulation Number
866.3378 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD Kiestra IdentifA is an Automated System for Sample Preparation and Identification of Microorganisms from Cultured Isolates by Mass Spectrometry, designed to streamline microbiological workflows. It leverages matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry to rapidly identify bacterial and fungal isolates, enhancing diagnostic accuracy and efficiency in clinical microbiology settings.

This system automates the preparation of a McFarland suspension for use with the BD Bruker MALDI Biotyper CA System, reducing manual labor and minimizing processing errors. Supplied as a reusable device, it is intended for use in clinical microbiology laboratories and has received FDA 510(k) clearance under the Traditional pathway (K191964). The device adheres to regulatory standards outlined in 21 CFR 866.3378 and is classified as a Class II medical device.

Frequently asked questions

What types of microorganisms can the BD Kiestra IdentifA identify, and how does it improve the workflow in a clinical microbiology lab?

The BD Kiestra IdentifA is designed to identify bacterial and fungal isolates using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry. It automates the preparation of a McFarland suspension, which is required for use with the BD Bruker MALDI Biotyper CA System, reducing manual labor and minimizing errors in sample preparation. This streamlines workflows by accelerating identification processes, improving diagnostic accuracy, and enhancing efficiency in clinical microbiology settings.

Is the BD Kiestra IdentifA a single-use or reusable device, and how does this affect its maintenance and cost?

The BD Kiestra IdentifA is a reusable device, which means it is designed for repeated use within a clinical microbiology laboratory. This approach reduces waste and can lower long-term costs, though it requires proper cleaning, maintenance, and validation to ensure consistent performance and sterility between uses. The reusable nature also allows for ongoing upgrades and compatibility with future software or accessory updates.

What regulatory pathway was followed for FDA clearance of the BD Kiestra IdentifA, and what does this mean for its use in clinical settings?

The BD Kiestra IdentifA received FDA clearance under the Traditional 510(k) pathway (K191964), specifically classified as substantially equivalent to a predicate device. This means the FDA determined that the device has the same intended use and technological characteristics as a legally marketed device, ensuring it meets regulatory standards outlined in 21 CFR 866.3378. Clinicians can rely on this clearance as evidence that the device has undergone rigorous review for safety and effectiveness in automated microorganism identification.

How is the BD Kiestra IdentifA supplied, and are there different models or sizes available?

The BD Kiestra IdentifA is supplied as a reusable automated system, intended for integration into clinical microbiology laboratories. While the provided data does not specify multiple models or sizes, its design focuses on compatibility with the BD Bruker MALDI Biotyper CA System for McFarland suspension preparation. Laboratories should confirm compatibility with their existing workflows and consult Becton, Dickinson and Company for any additional configurations or accessories that may be available.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Kiestra™ IdentifA, BD Kiestra™ Laboratory Automation Solutions, BD KIESTRA IDENTIFA USER MANUAL Pdf Download | ManualsLib, BD (company) - Wikipedia, BD Introduces Smart Connected Robotics to Automate Microbial ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K191964 24 fields · synced Sep 18, 2026