510(k) · Cleared
ClearedLithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Electron OY · NDW Assay, Porphyrin, Spectrophotometry, Lithium
Cleared on Oct 9, 2007 as substantially equivalent to K003583 (Trace America, Inc., 2001) and 1 other predicate after a 300-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 9, 2007
- Review
- 300 days
- Class
- Class II
- Product code
- NDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961462 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961462 Cedia Theophylline AssayBoehringer Mannheim Corp. · 1996
- This deviceK063705 Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2…Thermo Electron OY · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961462 | Cedia Theophylline Assay | Boehringer Mannheim Corp. | 1996 | — |
| 0 (this device) | K063705 | Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM… | Thermo Electron OY | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K003583 | Lithium Regent Model TR66056 / Lithium Standard TR66901Summary page 3…ed use F. Substantial Equivalence Thermo Electron, Australia/U.S.A The Infinity TM Lithium Reagent for Olympus® Analysers. (K003583) Microgenics Corporation item: The CEDIA® Theophylline II Assay. (K961462) G. Subs… | 2001 |
| * | K961462 | Cedia Theophylline AssaySummary page 3…The Infinity TM Lithium Reagent for Olympus® Analysers. (K003583) Microgenics Corporation item: The CEDIA® Theophylline II Assay. (K961462) G. Substantial equivalence -similarities Lithium Micro Volume Electrode is substantially equivalen… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K003583.
How does its category compare?
All NDW devicesNDW Assay, Porphyrin, Spectrophotometry, Lithium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
Lithium is intended for in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 Clinical Chemistry Analyzers. Measurements are used as an aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). Theophylline is intended for quantitative in vitro diagnostic determination of the theophylline concentration in human…
Read the full statement (164 words)
Lithium is intended for in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 Clinical Chemistry Analyzers. Measurements are used as an aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Theophylline is intended for quantitative in vitro diagnostic determination of the theophylline concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy.
The ISE Calibrators 1 and 2 & 3 are intended for calibration of ion selective electrodes for quantitative measurements of potassium, sodium and chloride in human serum or plasma and lithium in human serum. For the in vitro diagnostic use on the T60 analyzer.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063705 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063705: Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063705
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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