Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1600](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1600) → MZV — Test, System, Potassium, Enzymatic Method

# MZV · Test, System, Potassium, Enzymatic Method

_Clinical Chemistry · 21 CFR 862.1600 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZV

## Overview

- **Product Code:** MZV
- **Device Name:** Test, System, Potassium, Enzymatic Method
- **Regulation:** [21 CFR 862.1600](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1600)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

## Classification Rationale

Class II.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K200865](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZV/K200865.md) | Piccolo Potassium Test System | Abaxis, Inc. | Oct 20, 2021 | SESE |
| [K091455](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZV/K091455.md) | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL | Diazyme Laboratories | Aug 14, 2009 | SESE |
| [K053566](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZV/K053566.md) | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A | Diazyme Laboratories | Feb 15, 2006 | SESE |
| [K042191](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZV/K042191.md) | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT | Diazyme Laboratories | Oct 29, 2004 | SESE |

## Top Applicants

- Diazyme Laboratories — 3 clearances
- Abaxis, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZV](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MZV)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com