# K050374: Advia Ims Lithium Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Jun 15, 2005 after 121 days
- Product code: NDW (Assay, Porphyrin, Spectrophotometry, Lithium)
- Device class: 2
- Regulation: 21 CFR 862.3560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ThermoTrace Lithium: named in the summary without a submission number

## Most influential descendants
- K161494: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (2016), 2 descendants of its own
- K242685: Atellica® CH Creatinine_3 (Crea3) (2024), 1 descendant of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own

## Recalls of this device
- Sep 19, 2022 · Class II · Z-0105-2023: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappr
- Sep 19, 2022 · Class II · Z-0104-2023: Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappr
- Feb 9, 2022 · Class II · Z-0931-2022: Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
- Jun 5, 2020 · Class II · Z-2430-2020: Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
- Oct 7, 2016 · Class II · Z-0589-2017: Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on patient sampl
- Sep 24, 2013 · Class II · Z-0365-2014: Siemens Healthcare Diagnostics is conducting a field correction for Siemens Chemistry Calibrator Lots 090445B and 090445C on the ADVIA 1200, 1650, 1800, and 2400 Chemistry Systems. The System Specific

## Indications for use
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder. The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA®IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems. The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.

Source page: https://510kreport.com/device/K050374
Methodology: https://510kreport.com/methodology