GLQ · Mixture, Control, White-Cell And Red-Cell Indices
Hematology · 21 CFR 864.8625 · Class 2
Overview
| Product Code | GLQ |
|---|---|
| Device Name | Mixture, Control, White-Cell And Red-Cell Indices |
| 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K111211 | CELL-DYN 22 PLUS CONTROL | Streck | Dec 22, 2011 | SESE |
| K110718 | CELL-CHEX WITH CPPD CRYSTALS | Streck | May 26, 2011 | SESE |
| K101335 | CELL-CHEX | Streck | Aug 23, 2010 | SESE |
| K090137 | STAK-CHEX PLUS RETICS | Streck | Mar 18, 2009 | SESE |
| K000945 | PARA 12 PLUS RETICS | Streck Laboratories, Inc. | Apr 18, 2000 | SESE |
| K994388 | XE CHECK | Streck Laboratories, Inc. | Jan 14, 2000 | SESE |
| K992887 | STAK-CHEX PLUS RETICS | Streck Laboratories, Inc. | Nov 22, 1999 | SESE |
| K823794 | CONTROL TM 8 | General Diagnostics | Jan 14, 1983 | SESE |
| K823587 | UNI-CELL | Medical Specialties Laboratories | Jan 5, 1983 | SESE |
| K823498 | PARA 12 | Streck Laboratories, Inc. | Dec 28, 1982 | SESE |
Top Applicants
- Streck — 4 clearances
- Streck Laboratories, Inc. — 4 clearances
- General Diagnostics — 1 clearance
- Medical Specialties Laboratories — 1 clearance
