BD Kiestra IdentifA
by Becton, Dickinson and Company 2 variants
510(k) K222563
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK222563 | Date31 Aug 2023 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- QQV
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3378
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
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 integrates sample preparation with mass spectrometry-based identification, enabling rapid and accurate microbial species identification from cultured isolates. This system leverages automated processes to enhance precision and reduce manual intervention in laboratory settings.
The device is intended for use in clinical microbiology laboratories, where it automates the preparation of McFarland suspensions for downstream identification via the BD Bruker MALDI Biotyper CA System. Supplied as a reusable medical device, it adheres to FDA 510(k) clearance and In Vitro Diagnostic Regulation (IVDR) compliance. The system is classified under Device Class II and is regulated under FDA regulation number 866.3378, with registration numbers 3010141591, 1119779, 3002444944, and 3009288740. Storage and handling follow standard laboratory protocols for automated microbiology systems.
From the manufacturer
For products referenced on this page, the legal manufacturer remains Becton, Dickinson and Company or one of its affiliates or subsidiaries ("BD") until all required regulatory transfers are completed.
BD Kiestra™ IdentifA Powered by BD Synapsys™ informatics solution, the BD Kiestra™ IdentifA automates the preparation of a McFarland suspension for BD™ Bruker MALDI Biotyper® CA System identification, which may provide greater efficiency by reducing labor and processing errors.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
How does the BD Kiestra IdentifA integrate with existing lab workflows and what specific microbiological tasks does it automate?
The BD Kiestra IdentifA automates the preparation of McFarland suspensions from cultured microbial isolates, which is a critical step before identification via the BD Bruker MALDI Biotyper CA System. By streamlining this process, it reduces manual handling and enhances precision in clinical microbiology labs, helping to accelerate identification workflows while maintaining accuracy.
Is the BD Kiestra IdentifA a single-use or reusable device, and what are the implications for maintenance and cost?
The BD Kiestra IdentifA is designed as a reusable medical device, meaning it is built for long-term use in laboratory settings. This design allows for cost efficiency over time, as it eliminates the need for disposable components, though regular maintenance and cleaning per standard laboratory protocols for automated systems will be required to ensure optimal performance and sterility.
What regulatory pathways does the BD Kiestra IdentifA follow, and how does this affect its use in clinical settings?
The BD Kiestra IdentifA follows both FDA 510(k) clearance and In Vitro Diagnostic Regulation (IVDR) compliance, ensuring it meets stringent standards for safety, performance, and quality. This regulatory route confirms its suitability for use in clinical microbiology laboratories, where adherence to such standards is essential for reliable microbial identification and patient care.
How does the system’s mass spectrometry-based identification process differ from traditional microbiological methods, and what advantages does it offer?
Unlike traditional microbiological methods that rely on manual culturing and phenotypic testing, the BD Kiestra IdentifA uses mass spectrometry to rapidly analyze microbial protein fingerprints from cultured isolates. This method provides faster, more accurate species identification with reduced manual intervention, improving turnaround times and minimizing human error in clinical microbiology workflows.
What storage and handling requirements should be followed for the BD Kiestra IdentifA to ensure proper functionality and compliance?
The BD Kiestra IdentifA should be stored and handled according to standard laboratory protocols for automated microbiology systems. This includes maintaining a clean, controlled environment to prevent contamination, following manufacturer guidelines for maintenance, and ensuring proper calibration and cleaning routines to uphold performance, sterility, and regulatory compliance in clinical settings.