510(k) · Cleared
Recalled · Class II · 2020BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PMG Automated Multicolor Fluorescent Imaging Cytometric Analysis System
Cleared on Dec 17, 2015 as substantially equivalent to K071141 (Bd Biosciences, 2007) and 3 other predicates after a 265-day review. Its family tree reaches back 3 generations to 1992. It has been recalled once.
- Decided
- Dec 17, 2015
- Review
- 265 days
- Class
- Class II
- Product code
- PMG
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 3 generations to K920997 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK920997 CD-ChexStreck Laboratories, Inc. · 1992
- 2 generations backK961610 R & D Systems' Whole Blood Flow Control, (R & D - WBFC)R&D Systems, Inc. · 1996
- 1 generation backK982231 StatusflowR&D Systems, Inc. · 1998 · Recalled
- This deviceK150815 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto…Becton, Dickinson and Company · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920997 | CD-Chex | Streck Laboratories, Inc. | 1992 | — |
| −2 | K961610 | R & D Systems' Whole Blood Flow Control, (R & D - WBFC) | R&D Systems, Inc. | 1996 | — |
| −1 | K982231 | Statusflow | R&D Systems, Inc. | 1998 | 1 |
| 0 (this device) | K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb… | Becton, Dickinson and Company | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
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 PMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071141 | BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402Summary page 7…stem 5.3 Predicate Device BD FACSCalibur™ using BD Tritest CD3/CD4/CD45 with BD Trucount Tubes and BD MultiSet Software (K071141) R&D Systems’ Whole Blood Flow Control, also known as StatusFlow (K961610 & BK990005) … | 2007 |
| * | K961610 | R & D Systems' Whole Blood Flow Control, (R & D - WBFC)Summary page 7…5 with BD Trucount Tubes and BD MultiSet Software (K071141) R&D Systems’ Whole Blood Flow Control, also known as StatusFlow (K961610 & BK990005) StatusFlowLo (K982231) Eurotrol Hb 301 Control (Levels 1-3) (BK030067) 5.4 Referenc… | 1996 |
| Kept off the family tree | K990005 | FDA’s K990005 is Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System The summary prints BK990005, a CBER number, which our reading took as K990005, FDA’s number for Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System (Spinal Concepts, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “R&D Systems’ Whole Blood Flow Control (StatusFlow)”. Kept off the family tree. Summary page 7…rucount Tubes and BD MultiSet Software (K071141) R&D Systems’ Whole Blood Flow Control, also known as StatusFlow (K961610 & BK990005) StatusFlowLo (K982231) Eurotrol Hb 301 Control (Levels 1-3) (BK030067) 5.4 Reference Device –… | 1999 |
| * | K982231 | StatusflowSummary page 7…ltiSet Software (K071141) R&D Systems’ Whole Blood Flow Control, also known as StatusFlow (K961610 & BK990005) StatusFlowLo (K982231) Eurotrol Hb 301 Control (Levels 1-3) (BK030067) 5.4 Reference Device – Sysmex System Sysmex™ Automated… | 1998 |
| * | K030067 | Vitros Immunodiagnostic Products Hbsag ControlsSummary page 7…od Flow Control, also known as StatusFlow (K961610 & BK990005) StatusFlowLo (K982231) Eurotrol Hb 301 Control (Levels 1-3) (BK030067) 5.4 Reference Device – Sysmex System Sysmex™ Automated Hematology Analyzer KX-21N (K981761) 5.5 Predicate Device… | 2003 |
| † | K981761 | Sysmex KX-21, Automated Hematology Analyzer | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2020 | Class II | Z-0562-2021 | Process control | Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K071141.
How does its category compare?
All PMG devicesPMG Automated Multicolor Fluorescent Imaging Cytometric Analysis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PMG
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · PMG
Too few PMG 510(k)s in any year since 2007 to give a median.
Recalls per year · PMG
No recall names PMG since 2007.
Adverse event reports per year · PMG
1in 2021
MAUDE reports naming product code PMG, 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums. • For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and…
Read the full statement (378 words)
The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums.
• For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
• For use in children, adolescents, and adults.
• For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes.
• Not for point-of-care use.
• For in vitro diagnostic use.
The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
• For use in children, adolescents, and adults
• For use with human whole blood from fingerstick and/or venous collections in K2 EDTA or K3 EDTA blood collection tubes.
• Not for point-of-care use.
• For in vitro diagnostic use.
The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BD™ Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.
Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto™ System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150815: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150815
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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