Resolve Systems Alkaline Phosphatase Test Kit
by Isolab, Inc. 510(k)
Active
510(k) K934013
Overview
The Resolve Systems Alkaline Phosphatase Test Kit is an electrophoretic separation device for alkaline phosphatase isoenzymes, classified under Clinical Chemistry. It is designed to measure alkaline phosphatase or its isoenzymes in serum or plasma, aiding in the diagnostic evaluation of liver, bone, parathyroid, and intestinal conditions. The device facilitates biochemical analysis through electrophoretic separation techniques to differentiate enzyme variants.
This test kit is intended for in vitro diagnostic use in clinical chemistry laboratories. Supplied as a single-use reagent system, it requires no sterilization beyond manufacturer-provided packaging. The device is regulated under FDA 510(k) clearance (K934013) and falls under Class II medical devices (product code: CIN). Storage and handling follow standard laboratory protocols for diagnostic reagents, with no specific MRI safety considerations noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934013 | Date26 Apr 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CIN
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1050
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Isolab, Inc.
Questions
What is the Resolve Systems Alkaline Phosphatase Test Kit used for?
This test kit is designed for in vitro diagnostic use in clinical chemistry laboratories to measure alkaline phosphatase or its isoenzymes in serum or plasma. It helps differentiate enzyme variants through electrophoretic separation, supporting diagnostic evaluations for liver, bone, parathyroid, and intestinal conditions. The separation technique aids clinicians in identifying specific biochemical patterns linked to these conditions.
How is the Resolve Systems Alkaline Phosphatase Test Kit supplied?
The kit is supplied as a single-use reagent system. Each kit is individually packaged by the manufacturer, eliminating the need for additional sterilization beyond what is provided in the packaging. This ensures consistency and safety for each use.
Is the Resolve Systems Alkaline Phosphatase Test Kit reusable?
No, the kit is intended for single-use only. The design and packaging are optimized for one-time diagnostic testing to maintain accuracy and prevent cross-contamination between samples. Reuse is not recommended or supported by the manufacturer.
What storage and handling guidelines apply to this test kit?
The kit should be stored and handled according to standard laboratory protocols for diagnostic reagents. This includes maintaining appropriate temperature conditions, protecting from light exposure, and ensuring the packaging remains intact until use. Specific storage instructions are detailed in the manufacturer’s accompanying documentation.
Does this test kit require any special regulatory considerations?
The Resolve Systems Alkaline Phosphatase Test Kit is regulated under FDA 510(k) clearance (K934013) and classified as a Class II medical device under product code CIN. It is intended for use in clinical chemistry laboratories and adheres to the regulatory framework for in vitro diagnostic devices in the United States. No additional MRI safety considerations are noted.