Glucose, Hexokinase (R1), Model GL101-01, Glucose Hexokinase (R2), Model GL101-02
510(k) K990981
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990981 | Date25 May 1999 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- CFR
- Models / Variants
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Glucose, Hexokinase (R1), Model GL101-01, and Glucose Hexokinase (R2), Model GL101-02 are reagents used in a hexokinase-based enzymatic assay to determine glucose concentration in clinical samples. These reagents assist clinicians in the diagnosis and management of glucose metabolism disorders, such as diabetes mellitus.
The device is intended for in vitro diagnostic use in the quantitative determination of glucose in serum, plasma, and CSF. It is a Class II medical device with FDA 510(k) clearance (K990981) and is classified under product code CFR with special controls. The device is manufactured by A.P. Total Care, Inc.
Other devices from A.P. Total Care, Inc.
Questions
AI-generated answers, 28 Sep 2026
What are the Glucose Hexokinase reagents used for?
These reagents are used in hexokinase-based enzymatic assays to determine glucose concentration in clinical samples, assisting clinicians in the diagnosis and management of glucose metabolism disorders such as diabetes mellitus.
What sample types can be tested with these reagents?
The Glucose Hexokinase reagents are intended for in vitro diagnostic use in the quantitative determination of glucose in serum, plasma, and cerebrospinal fluid (CSF) samples.
What is the regulatory status of these reagents?
These reagents are Class II medical devices with FDA 510(k) clearance (K990981) and are classified under product code CFR with special controls, manufactured by A.P. Total Care, Inc.
Are these reagents single-use or reusable?
The device data does not specify whether these reagents are single-use or reusable. This information would typically be found in the product's instructions for use, which should be consulted for proper handling and disposal procedures.