CareSide Glucose
by Exigent Diagnostics, Inc. 510(k)
Active
510(k) K981183
Overview
The CareSide Glucose is a glucose oxidase-based in vitro diagnostic device designed to quantitatively measure glucose concentration in whole blood, plasma, or serum. Classified under the product code CGA, it operates as a reagent cartridge intended for laboratory use by trained professionals.
This device is supplied as a single-use cartridge and is intended for use with the CareSide Analyzer. It is regulated under FDA 510(k) clearance (K981183) and falls under Class II with special controls. The device is not described as MRI-safe, reusable, or sterile in the provided data. Storage and handling conditions are not specified beyond standard in vitro diagnostic practices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981183 | Date7 May 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- CGA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Exigent Diagnostics, Inc.
Questions
What is the CareSide Glucose cartridge used for?
The CareSide Glucose cartridge is designed to quantitatively measure glucose concentrations in whole blood, plasma, or serum. It uses a glucose oxidase-based method to provide accurate results for laboratory testing, supporting clinical chemistry diagnostics.
How is the CareSide Glucose cartridge supplied and intended for use?
The cartridge is supplied as a single-use reagent cartridge and is intended exclusively for use with the CareSide Analyzer. It is engineered for laboratory environments and requires trained professionals to operate it safely and effectively.
Is the CareSide Glucose cartridge sterile or reusable?
The provided data does not specify whether the CareSide Glucose cartridge is sterile. However, it is explicitly described as a single-use device, meaning it is not intended for reuse after one test.
What regulatory pathway does the CareSide Glucose cartridge follow?
The CareSide Glucose cartridge is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K981183. It is classified as a Class II medical device with special controls and falls under the product code CGA for clinical chemistry applications.
Are there any special storage or handling requirements for the CareSide Glucose cartridge?
The data does not provide specific storage or handling instructions beyond standard practices for in vitro diagnostic devices. Users should follow manufacturer guidelines to ensure proper conditions for accuracy and reliability.