510(k) · Cleared
Recalled · Class II · 2020Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (Alpi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Aug 28, 2012 as substantially equivalent to K991576 (Bayer Corp., 1999) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1986. It has been recalled once.
- Decided
- Aug 28, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- CJO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K860021 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- 1 generation backK061818 Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal -…Dade Behring, Inc. · 2006 · Recalled
- This deviceK122323 Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge…Siemens Healthcare Diagnostics · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860021 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | 1 |
| −1 | K061818 | Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330) | Dade Behring, Inc. | 2006 | 1 |
| 0 (this device) | K122323 | Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension… | Siemens Healthcare Diagnostics | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 CJO? 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? (2)
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 |
|---|---|---|---|
| * | K991576 | Additional Assays for the Bayer Advia 1650 Chemistry SystemSummary page 1…substantial equivalence to the Dimension®& Phosphatase (ALP!) Flex®& reagent cartridge is the ADVIA® Chemistry Alkaline Phosphatase AMP Method previously cleared under k991576. The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Alkaline Phosphatase Calibrator (ALP!… | 1999 |
| * | K061818 | Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)Summary page 1…bstantial equivalence to the Dimension Vista® Alkaline Phosphatase Calibrator (ALP! CAL) is the Dimension Vista® Alkaline Phosphatase Calibrator previously cleared under k0618 18. 7. Device Description: The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of… | 2006 |
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 |
|---|---|---|---|---|
| Aug 25, 2020 | Class II | Z-0134-2021 | Under Investigation by firm | Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 20.4 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 11 other devices also cite its predicate K991576.
How does its category compare?
All CJO devicesCJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CJO
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · CJO
Too few CJO 510(k)s in any year since 2007 to give a median.
Recalls per year · CJO
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJO
1in 2010
MAUDE reports naming product code CJO, 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 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 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 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 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 ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension Vista® System. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122323: Dimension Vista Alkaline Phosphatase (Alpi) Flex Reagent Cartridge Dimension Vista Alkaline Phosphatase Calibrator (Alpi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122323
Report an extraction error
Are you the manufacturer?
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