# K112142: Dimension Vista Lithium Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Nov 4, 2011 after 101 days
- Product code: NDW (Assay, Porphyrin, Spectrophotometry, Lithium)
- Device class: 2
- Regulation: 21 CFR 862.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011033 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011033: Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132, Dade Behring, Inc. (2001) Summary page 2.
- K011035: Dimension Drug Calibrator, Model DC22B, Dade Behring, Inc. (2001)

## Recalls of this device
- Feb 21, 2013 · Class II · Z-1151-2013: Siemens has confirmed complaints of low QC and patient recovery with the Dimension Vista(R) LOCI(R) Digoxin(DIGXN) Flex(R) reagent cartridge when calibrating DIGXN with either Drug 4 Cal (KC460) lot 2

## Indications for use
The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder). The Drug 4 Calibrator is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.

Source page: https://510kreport.com/device/K112142
Methodology: https://510kreport.com/methodology