GGM · Control, Hemoglobin
Hematology · 21 CFR 864.8625 · Class 2
Overview
| Product Code | GGM |
|---|---|
| Device Name | Control, Hemoglobin |
| Regulation | 21 CFR 864.8625 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
Classification Rationale
Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | Eurotrol B.V. | Nov 15, 2019 | SESE |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | Eurotrol B.V. | Feb 1, 2019 | SESE |
| K070546 | LYPHOCHEK DIABETES CONTROL | Bio-Rad Laboratories | Apr 2, 2007 | SESE |
| K070334 | R&D SICKLE QC CONTROL | R&D Systems, Inc. | Mar 29, 2007 | SESE |
| K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 | Bio-Rad | Nov 9, 2005 | SESE |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | Quantimetrix Corp. | Oct 30, 2003 | SESE |
| K003030 | LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET | Bio-Rad | Nov 29, 2000 | SESE |
| K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL | R&D Systems, Inc. | Nov 12, 1999 | SESE |
| K964052 | HEMOCUE HEMOTROL | Direct Solutions | Nov 6, 1996 | SESE |
| K963908 | HEMOCUE HEMOLIN | Direct Solutions | Oct 16, 1996 | SESE |
| K921681 | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL | Isolab, Inc. | Nov 17, 1992 | SESE |
| K893985 | HGB-CONTROL SET/MULTIPLE | R&D Systems, Inc. | Aug 15, 1989 | SESE |
| K852136 | PRECINORM HB | Boehringer Mannheim Corp. | Jul 5, 1985 | SESE |
| K800296 | WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 | Dade, Baxter Travenol Diagnostics, Inc. | Mar 5, 1980 | SESE |
| K790310 | HEMOGLOBIN CONTROLS | Electrophoresis Corp. | Mar 21, 1979 | SESE |
Top Applicants
- R&D Systems, Inc. — 3 clearances
- Bio-Rad — 2 clearances
- Direct Solutions — 2 clearances
- Eurotrol B.V. — 2 clearances
- Bio-Rad Laboratories — 1 clearance
