# K070987: Sentinel Lithium Assay

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: Aug 2, 2007 after 118 days
- Product code: NDW (Assay, Porphyrin, Spectrophotometry, Lithium)
- Device class: 2
- Regulation: 21 CFR 862.3560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003583 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 1.

## Recalls of this device
- Jun 28, 2019 · Class II · Z-2552-2019: Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydr
- Jun 28, 2019 · Class II · Z-2551-2019: Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydr

## Indications for use
A lithium test system is a device intended to measure lithium levels in serum or plasma. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). For use on Architect and Aeroset analyzers.

Source page: https://510kreport.com/device/K070987
Methodology: https://510kreport.com/methodology