Easy-Test Potassium K Item Number 19XXX
by Em Diagnostic Systems, Inc.
510(k) K880339
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880339 | Date25 Feb 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
Overview
AI-generated summary, 1 Oct 2026
The Easy-Test Potassium K Item Number 19XXX is a tetraphenyl borate colorimetry device for measuring potassium levels in clinical chemistry. It operates by reacting potassium ions with tetraphenyl borate to produce a colored complex, enabling quantitative analysis of serum or plasma samples. This method is designed for use in laboratory settings to assess electrolyte balance, particularly potassium concentration, which is critical for diagnosing and monitoring conditions such as hyperkalemia or hypokalemia.
This device is supplied as a single-use reagent kit and requires manual handling in a clinical laboratory environment. It is classified under FDA regulation 862.1600 and was granted FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE). The product code CEJ aligns it with similar potassium testing devices. No MRI safety or sterility specifications are noted in the regulatory data, and storage conditions are not detailed beyond standard laboratory practices for reagent kits.
Other devices from Em Diagnostic Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Easy-Test Potassium K 19XXX used for?
The Easy-Test Potassium K 19XXX is a tetraphenyl borate colorimetry device designed for measuring potassium levels in clinical chemistry. It reacts with potassium ions to produce a colored complex, enabling quantitative analysis of serum or plasma samples. This helps diagnose and monitor conditions like hyperkalemia or hypokalemia by assessing electrolyte balance in laboratory settings.
How is the Easy-Test Potassium K 19XXX supplied and used?
This device is supplied as a single-use reagent kit, meaning each kit is intended for one-time use in a clinical laboratory environment. It requires manual handling and is not automated. The kit is specifically designed for use in labs to perform potassium measurements on serum or plasma samples.
Is the Easy-Test Potassium K 19XXX sterile?
The regulatory data for the Easy-Test Potassium K 19XXX does not specify sterility requirements. Since it is a single-use reagent kit for laboratory use, standard laboratory practices for reagent handling should be followed, though no explicit sterility claims or certifications are mentioned.
What are the storage requirements for the Easy-Test Potassium K 19XXX?
The storage conditions for the Easy-Test Potassium K 19XXX are not detailed beyond standard laboratory practices for reagent kits. It is recommended to store the kit in a clean, dry environment, protected from extreme temperatures and direct light, as with other reagent-based diagnostic devices.
What regulatory pathway was used for the Easy-Test Potassium K 19XXX?
The Easy-Test Potassium K 19XXX received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE). This classification aligns it with existing potassium testing devices under product code CEJ and falls under FDA regulation 862.1600 for clinical chemistry devices.