Potassium Test Kit (K832553)
by Mallinckrodt Critical Care 510(k)
Active
510(k) K832553
Overview
This device is a Tetraphenyl Borate, Colorimetry, Potassium test kit, classified under Clinical Chemistry nomenclature. It is designed for the quantitative measurement of potassium levels in blood or serum samples using colorimetric analysis, leveraging tetraphenyl borate chemistry to detect potassium ions.
The Potassium Test Kit (K832553) is intended for use in clinical chemistry laboratories and is supplied as a single-use diagnostic reagent. It was cleared by the FDA under a Traditional 510(k) pathway (K832553) in 1983, adhering to Class II regulatory controls (product code CEJ). No information regarding sterility, MRI safety, or reusable components is provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832553 | Date20 Sep 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Potassium Test Kit
- 510(k) Number
- FDA Product Code
- CEJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1600
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Mallinckrodt Critical Care
Questions
What is the primary purpose of the Potassium Test Kit, and how does it work in a clinical setting?
The Potassium Test Kit (K832553) is designed for the quantitative measurement of potassium levels in blood or serum samples within clinical chemistry laboratories. It uses a colorimetric method with tetraphenyl borate chemistry to detect potassium ions, producing a measurable color change that correlates to the potassium concentration in the sample.
Is this test kit intended for single-use or repeated use, and what does that mean for my lab’s workflow?
The Potassium Test Kit is explicitly supplied as a single-use diagnostic reagent, meaning each kit is intended for one test only. This design ensures accuracy and consistency per the manufacturer’s specifications, so you’ll need to use a new kit for each sample to avoid contamination or degradation of results.
What regulatory pathway was followed for this device, and what does that mean for its use in my facility?
This kit was cleared by the FDA under a Traditional 510(k) pathway (K832553) in 1983, classified as a Class II device under product code CEJ (Clinical Chemistry). This means it adheres to FDA’s regulatory controls for moderate-risk devices, ensuring compliance with established safety and performance standards for in vitro diagnostic use.
Are there any special handling or storage requirements for this test kit?
The provided specifications do not explicitly detail sterility, storage conditions, or shelf-life requirements, but as a single-use diagnostic reagent, it should be stored according to the manufacturer’s instructions (likely in a dry, controlled environment) to maintain reagent stability. Always refer to the accompanying documentation for precise storage guidance.
What types of samples can this kit analyze, and is it compatible with standard lab equipment?
The kit is designed for blood or serum samples and operates via colorimetric analysis, meaning it requires standard laboratory equipment capable of measuring colorimetric reactions (e.g., spectrophotometers or colorimeters). No special equipment is mentioned beyond typical clinical chemistry lab tools.