GLK · Control, Hematocrit
Hematology · 21 CFR 864.8625 · Class 2
Overview
| Product Code | GLK |
|---|---|
| Device Name | Control, Hematocrit |
| 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121467 | EUROTROL HEMATOCRIT CONTROL | Eurotrol B.V. | May 10, 2013 | SESE |
| K021924 | MEDICA EASYQC HEMATOCRIT CONTROL | Bionostics, Inc. | Jun 24, 2002 | SESE |
| K020618 | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL | Aalto Scientific, Ltd. | May 14, 2002 | SESE |
| K964452 | HEMATACHEK | Richmond Diagnostics, Inc. | Feb 20, 1997 | SESE |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Ciba Corning Diagnostics Corp. | Jul 26, 1996 | SESE |
| K924926 | MSI-HCT | Medical Specialties, Inc. | Jan 7, 1993 | SESE |
| K893562 | A.QC HCT LEVEL 1 AND 2 | Johnson & Johnson Professionals, Inc. | Jul 14, 1989 | SESE |
Top Applicants
- Aalto Scientific, Ltd. — 1 clearance
- Bionostics, Inc. — 1 clearance
- Ciba Corning Diagnostics Corp. — 1 clearance
- Eurotrol B.V. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
