# K063705: Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron OY
- Decided: Oct 9, 2007 after 300 days
- Product code: NDW (Assay, Porphyrin, Spectrophotometry, Lithium)
- Device class: 2
- Regulation: 21 CFR 862.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961462 (1996). 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)
- K003583: Lithium Regent Model TR66056 / Lithium Standard TR66901, Trace America, Inc. (2001) Summary page 3.
- K961462: Cedia Theophylline Assay, Boehringer Mannheim Corp. (1996) Summary page 3.

## Indications for use
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.

Source page: https://510kreport.com/device/K063705
Methodology: https://510kreport.com/methodology