510(k) · Cleared
Recalled · Class II · 2022Advia Ims Lithium Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · NDW Assay, Porphyrin, Spectrophotometry, Lithium
Cleared on Jun 15, 2005 after a 121-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 15, 2005
- Review
- 121 days
- Class
- Class II
- Product code
- NDW
- Recalls
- 6
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK050374 Advia Ims Lithium AssayBayer Healthcare, LLC · 2005
- Descendant · cites it directly · 2 of its ownK161494 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK242685 Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK251058 Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025
Most influential descendants
Showing 3 of 3 · See all- K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc. · 2016 · cites it directly2descendants
- K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. · 2024 · 2 generations on1descendant
- K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050374 | Advia Ims Lithium Assay | Bayer Healthcare, LLC | 2005 | — |
| +1 | K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | 2016 | 1 |
| +2 | K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
| +3 | K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 NDW? 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 |
|---|---|---|---|
| * | — | ThermoTrace Lithium Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | 2016 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2022 | Class II | Z-0105-2023 | Under Investigation by firm | 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 inappropriate dosage adjustment, potentially… |
| Sep 19, 2022 | Class II | Z-0104-2023 | Under Investigation by firm | 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 inappropriate dosage adjustment, potentially… |
| Feb 9, 2022 | Class II | Z-0931-2022 | Device Design | 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 | Nonconforming Material/Component | 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 | Under Investigation by firm | 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 samples compared to the reference method… |
| Sep 24, 2013 | Class II | Z-0365-2014 | Under Investigation by firm | 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 Values (SSVs) for the Direct… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161494 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NDW devicesNDW Assay, Porphyrin, Spectrophotometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDW
Too few NDW 510(k)s in any year since 2007 to give a median.
Recalls per year · NDW
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDW
2in 2025
MAUDE reports naming product code NDW, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050374: Advia Ims Lithium Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050374
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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