LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine Reagent
510(k) K172232
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172232 | Date12 Jun 2019 | 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- Withdrawn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
- LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
- 510(k) Number
- FDA Product Code
- JGS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1665
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The LIASYS 600 Electrolyte Measurement System is an ion-specific electrode device designed for the quantitative measurement of electrolytes and creatinine in human serum. It operates as a clinical chemistry analyzer, utilizing specific reagents to detect sodium and creatinine levels. These measurements are critical for diagnosing renal diseases, monitoring dialysis patients, and assessing overall kidney function. The system integrates with its corresponding LIASYS 600 Creatinine reagent for accurate, standardized testing.
The LIASYS 600 system is intended for use in clinical laboratories and healthcare settings where renal function assessment is required. It is supplied as a reusable analyzer paired with single-use creatinine reagents, ensuring precision and consistency in results. The device is authorized under FDA 510(k) clearance (K172232) as an ion-specific electrode (product code JGS) for sodium measurement, classified under Class II Special Controls. Storage and handling follow standard clinical chemistry protocols, with no noted MRI safety restrictions.
Questions
AI-generated answers, 1 Oct 2026
What clinical conditions does the LIASYS 600 help diagnose or monitor?
The LIASYS 600 Electrolyte Measurement System is designed for quantitative measurement of sodium and creatinine in human serum, which are critical for diagnosing renal diseases and monitoring dialysis patients. Accurate sodium levels help assess electrolyte balance, while creatinine measurements provide insight into kidney function, making it essential for assessing overall renal health and managing conditions like chronic kidney disease or acute kidney injury.
How is the LIASYS 600 supplied, and what type of reagents does it use?
The LIASYS 600 comes as a reusable clinical chemistry analyzer paired with single-use LIASYS 600 Creatinine reagents. This design ensures precision and consistency in results while minimizing cross-contamination risks. The single-use reagents are specifically formulated for compatibility with the system, providing standardized testing for creatinine alongside sodium measurements.
Is the LIASYS 600 system sterile, and how should it be handled?
The LIASYS 600 analyzer itself is not sterile as it is a reusable device intended for use in controlled clinical laboratory environments. However, the single-use creatinine reagents are designed for sterile testing to prevent contamination. Standard clinical chemistry protocols should be followed for storage, handling, and maintenance of the analyzer, including proper cleaning and calibration procedures to ensure accurate and reliable results.
Can the LIASYS 600 be used in MRI environments, and what safety considerations apply?
The LIASYS 600 Electrolyte Measurement System does not have any noted MRI safety restrictions. However, since it is an electronic device, it should not be exposed to strong magnetic fields unless explicitly tested and approved for such environments. Always follow facility-specific guidelines for handling medical devices near MRI equipment to ensure patient and staff safety.
What regulatory clearance does the LIASYS 600 have, and what does that mean for its use?
The LIASYS 600 Electrolyte Measurement System holds FDA 510(k) clearance (K172232) as an ion-specific electrode for sodium measurement, classified under Class II Special Controls. This clearance indicates that the device has been reviewed and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for clinical use in renal function assessment. The clearance does not imply approval for all possible clinical applications but confirms compliance with regulatory requirements for its intended use.