# K122398: Rapidpoint 500 System Measurement Cartridge with Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 12, 2012 after 66 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963926 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100344: Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605, Siemens Healthcare Diagnostics (2011) Summary page 1.

## Recalls of this device
- Oct 26, 2023 · Class II · Z-0608-2024: 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 diagnos
- Oct 26, 2023 · Class II · Z-0607-2024: 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 diagnos
- Oct 26, 2023 · Class II · Z-0606-2024: 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 diagnos
- Oct 26, 2023 · Class II · Z-0609-2024: 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 diagnos

## Indications for use
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).

Source page: https://510kreport.com/device/K122398
Methodology: https://510kreport.com/methodology