CGE · Orthotoluidine, Glucose
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | CGE |
|---|---|
| Device Name | Orthotoluidine, Glucose |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Classification Rationale
Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Alpkem Corp. | Feb 17, 1989 | SESE |
| K855185 | GLUCOSE REAGENT SET | Technostics Intl. | Jan 22, 1986 | SESE |
| K850930 | GLUCOSE | Dilab, Inc. | Jun 10, 1985 | SESE |
| K841054 | DIRECT GLUCOSE REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K821198 | DIRECT GLUCOSE REAGENT SET | Omega Medical Electronics | Jul 13, 1982 | SESE |
| K811883 | KING DIAGNOSTICS GLUCOSE-O TEST | King Diagnostics, Inc. | Jul 23, 1981 | SESE |
| K810089 | 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI | Anco Medical Reagents & Assoc. | Jan 26, 1981 | SESE |
| K790319 | ORTHO-TOLUIDINE REAGENT SET | Fisher Scientific Co., LLC | Mar 21, 1979 | SESE |
| K781308 | GLUCOLOUR | Analytical & Research Chemicals, Inc. | Aug 31, 1978 | SESE |
| K771314 | GLUCOSE REAGENT (O-TOLUIDINE) | Mallinckrodt Critical Care | Aug 3, 1977 | SESE |
| K771091 | UNIPAK GLUCOSE | Harleco | Jul 21, 1977 | SESE |
| K770455 | GLUCOSE PROCEDURE, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | May 3, 1977 | SESE |
Top Applicants
- Alpkem Corp. — 1 clearance
- Analytical & Research Chemicals, Inc. — 1 clearance
- Anco Medical Reagents & Assoc. — 1 clearance
- Dilab, Inc. — 1 clearance
- Fisher Scientific Co., LLC — 1 clearance
