SERA-210 Electrolyte Analyzer
510(k) K844806
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844806 | Date8 Jan 1985 | 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- Withdrawn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
- Full name
- Modify Electrolyte Analyzer Model Sera-210
- 510(k) Number
- FDA Product Code
- CEM
- 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 Sera-210 Electrolyte Analyzer is an Electrode, Ion Specific, Potassium device, designed for the quantitative measurement of potassium ion concentrations in clinical chemistry. It employs ion-selective electrodes to accurately determine electrolyte levels in serum or plasma samples, supporting diagnostic assessments in clinical settings. The analyzer is categorized under the Clinical Chemistry specialty and adheres to regulatory standards for Class II devices under FDA classification.
This device is intended for use in clinical laboratories and medical facilities, where it operates as a standalone analyzer for routine electrolyte testing. Supplied as a reusable instrument, the Sera-210 requires proper calibration and maintenance to ensure precision. It is not MRI-compatible and must be stored in a controlled environment to preserve functionality. The device holds FDA 510(k) clearance (K844806) under the Substantially Equivalent determination, with regulatory oversight under 21 CFR 862.1600. No sterility claims are associated with this device.
Other devices from Horiba Instruments, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Sera-210 Electrolyte Analyzer used for?
The Sera-210 Electrolyte Analyzer is designed specifically for the quantitative measurement of potassium ion concentrations in clinical chemistry. It uses ion-selective electrodes to provide accurate electrolyte level readings in serum or plasma samples, supporting diagnostic assessments in clinical settings such as hospitals and laboratories. This precision aids in monitoring conditions like electrolyte imbalances, kidney function, and cardiac health.
Is the Sera-210 Electrolyte Analyzer reusable or single-use?
The Sera-210 Electrolyte Analyzer is a reusable instrument. It is built as a standalone analyzer for routine electrolyte testing, requiring proper calibration and maintenance to ensure consistent and reliable performance over time. This design makes it suitable for long-term use in clinical environments where durability and repeated testing are essential.
Does the Sera-210 require any special storage conditions?
Yes, the Sera-210 must be stored in a controlled environment to maintain its functionality. While the device itself is not sterile, it is critical to protect it from environmental factors like extreme temperatures, humidity, and physical damage. Proper storage ensures the analyzer’s electrodes and internal components remain accurate and operational for precise potassium measurements.
Can the Sera-210 Electrolyte Analyzer be used in an MRI environment?
No, the Sera-210 Electrolyte Analyzer is explicitly stated as not MRI-compatible. This means it should not be placed in or near an MRI scanner, as exposure to magnetic fields could compromise its performance or safety. Clinicians must ensure the device is used in non-MRI areas to avoid potential risks or malfunctions.
What regulatory approval does the Sera-210 hold?
The Sera-210 Electrolyte Analyzer holds FDA 510(k) clearance under the determination of Substantially Equivalent (K844806). This classification falls under the regulatory oversight of 21 CFR 862.1600, confirming it meets the necessary safety and performance standards for use in clinical chemistry applications. The device is categorized as a Class II medical device.