510(k) · Cleared
ClearedBD Kiestra IdentifA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Cleared on Aug 31, 2023 as substantially equivalent to K191964 (Becton, Dickinson and Company, 2021) after a 372-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Aug 31, 2023
- Review
- 372 days
- Class
- Class II
- Product code
- QQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170081 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QQV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QQV device
- #1 K223245 Colibríscore 9.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191964 | BD Kiestra IdentifASummary page 9…confidence identification) and no statistical difference in performance (paired chi square P value = 0.368) compared to the standard workflow. The results from K191964 are acceptable. No changes were made to Quality Control for this submission. V Substantial Equivalence Informati… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QQV devicesQQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QQV
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QQV
Too few QQV 510(k)s in any year since 2007 to give a median.
Recalls per year · QQV
No recall names QQV since 2007.
Adverse event reports per year · QQV
1in 2024
MAUDE reports naming product code QQV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (111 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222563: BD Kiestra IdentifA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222563
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026