Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3560](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3560) → NDW — Assay, Porphyrin, Spectrophotometry, Lithium

# NDW · Assay, Porphyrin, Spectrophotometry, Lithium

_Clinical Toxicology · 21 CFR 862.3560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW

## Overview

- **Product Code:** NDW
- **Device Name:** Assay, Porphyrin, Spectrophotometry, Lithium
- **Regulation:** [21 CFR 862.3560](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3560)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

## Classification Rationale

Class II.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243462](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K243462.md) | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | Aug 1, 2025 | SESE |
| [K112142](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K112142.md) | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | Nov 4, 2011 | SESE |
| [K063684](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K063684.md) | COBAS LITHIUM | Roche Diagnostics Corp. | Mar 21, 2008 | SESE |
| [K063705](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K063705.md) | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL | Thermo Electron OY | Oct 9, 2007 | SESE |
| [K070987](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K070987.md) | SENTINEL LITHIUM ASSAY | SENTINEL CH. SpA | Aug 2, 2007 | SESE |
| [K050374](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K050374.md) | ADVIA IMS LITHIUM ASSAY | Bayer Healthcare, LLC | Jun 15, 2005 | SESE |
| [K003583](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K003583.md) | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | Trace America, Inc. | Jan 17, 2001 | SESE |

## Top Applicants

- Bayer Healthcare, LLC — 1 clearance
- Diazyme Laboratories, Inc. — 1 clearance
- Roche Diagnostics Corp. — 1 clearance
- SENTINEL CH. SpA — 1 clearance
- Siemens Healthcare Diagnostics — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW)

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