510(k) · Cleared
Recalled · Class II · 2023Rapidpoint 500 System Measurement Cartridge with Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Oct 12, 2012 as substantially equivalent to K100344 (Siemens Healthcare Diagnostics, 2011) after a 66-day review. Its family tree reaches back 4 generations to 1997. It has been recalled 4 times.
- Decided
- Oct 12, 2012
- Review
- 66 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963926 (1997). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK963926 Axsym CA 15-3Abbott Laboratories · 1997 · Recalled
- 3 generations backK033036 BR Monitor and BR Monitor Calibrators on the Access Immunoassay…Beckman Coulter, Inc. · 2004 · Recalled
- 2 generations backK072612 Access Immunoassay Systems BR Monitor, and Calibrators, Model (S)…Beckman Coulter, Inc. · 2007 · Recalled
- 1 generation backK100344 Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics · 2011 · Recalled
- This deviceK122398 Rapidpoint 500 System Measurement Cartridge with CalibratorsSiemens Healthcare Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963926 | Axsym CA 15-3 | Abbott Laboratories | 1997 | 4 |
| −3 | K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model… | Beckman Coulter, Inc. | 2004 | 1 |
| −2 | K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and… | Beckman Coulter, Inc. | 2007 | 1 |
| −1 | K100344 | Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7… | Siemens Healthcare Diagnostics | 2011 | 1 |
| 0 (this device) | K122398 | Rapidpoint 500 System Measurement Cartridge with Calibrators | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 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 JIX? 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? (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 |
|---|---|---|---|
| * | K100344 | Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Summary page 1…te Device: The predicate device used to demonstrate substantial equivalence is the Dimension Vista® LOCI 7 Calibrator, Models: K6456 and KC605, cleared under k1 00344. G. Device Description: The RAPIDPoint® 500 System consists of four (4) calibrators contained in the measurement c… | 2011 |
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 26, 2023 | Class II | Z-0608-2024 | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary… |
| Oct 26, 2023 | Class II | Z-0607-2024 | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary… |
| Oct 26, 2023 | Class II | Z-0606-2024 | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary… |
| Oct 26, 2023 | Class II | Z-0609-2024 | Under Investigation by firm | RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The RAPIOPoint®500 System measurement cartridge with calibrators is an in vitro diagnostic product for the calibration of the analytes on the RAPlOPoint® 500 System. The analytes measured are partial pressure of carbon dioxide (p002), partial pressure of oxygen (p302), pH, Sodium (Nat), Potassium (K+), ionized Calcium (Ca++), Chloride (CI-) Glucose (Glu), total hemoglobin (tHb), Neonatal Bilirubin and Lactate (Lac).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122398: Rapidpoint 500 System Measurement Cartridge with Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122398
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