Careside Amylase
by Careside, Inc. 510(k)
Active
510(k) K990025
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990025 | Date8 Feb 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JFJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1070
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Careside Amylase is a catalytic method device for amylase measurement, designed to quantify amylase activity in clinical chemistry. It operates as a single-use disposable cartridge, incorporating a multi-layer reagent film to facilitate biochemical reactions for accurate analyte detection. This device falls under the classification of catalytic methods and is intended for use in laboratory settings where precise enzymatic assays are required.
This device is supplied as a single-use cartridge and is used in conjunction with the Careside Analyzer to measure amylase levels in whole blood, serum, or plasma. It is regulated under FDA 510(k) clearance (K990025) and falls under the Class II medical device category (regulation number 862.1070). The cartridge is non-sterile and intended for in vitro diagnostic use, with no specific MRI safety or reuse restrictions noted in the data. Storage conditions are not detailed but are typically consistent with standard laboratory reagent storage practices.
Other devices from Careside, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Careside Amylase used for?
The Careside Amylase is a single-use disposable cartridge designed for measuring amylase activity in clinical chemistry. It uses a multi-layer reagent film to facilitate biochemical reactions, enabling accurate detection of amylase levels in whole blood, serum, or plasma. This makes it ideal for laboratory settings where precise enzymatic assays are required.
How is the Careside Amylase supplied and used?
The device is supplied as a single-use cartridge and is intended for use exclusively with the Careside Analyzer. Each cartridge contains the necessary reagents for one measurement, ensuring consistency and accuracy. Since it is disposable, no cleaning or reuse is required, reducing the risk of cross-contamination.
Is the Careside Amylase sterile?
No, the Careside Amylase cartridge is explicitly labeled as non-sterile. It is intended for in vitro diagnostic use, meaning it is designed for laboratory testing outside the human body. Sterility is not required for this type of assay, as it is not implanted or used in sterile body environments.
Can the Careside Amylase cartridge be reused?
No, the Careside Amylase is designed as a single-use disposable cartridge. Reuse is not recommended or supported by the manufacturer, as it could compromise the accuracy of results or introduce contamination. Each cartridge is intended for one measurement only.
What storage conditions should be followed for the Careside Amylase?
While specific storage conditions are not detailed in the provided data, the Careside Amylase should be stored according to standard laboratory reagent practices. This typically includes keeping the cartridges in a clean, dry environment, protected from extreme temperatures, direct sunlight, and moisture, to preserve reagent integrity and ensure accurate measurements.