JPK · Mixture, Hematology Quality Control
Hematology · 21 CFR 864.8625 · Class 2
Overview
| Product Code | JPK |
|---|---|
| Device Name | Mixture, Hematology Quality Control |
| 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 (20 of 192)
Showing 20 most recent of 192 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160590 | XN CHECK | Streck | Dec 22, 2016 | SESE |
| K160588 | XN CHECK BF | Streck | Dec 22, 2016 | SESE |
| K160586 | XN-L CHECK | Streck | Dec 22, 2016 | SESE |
| K160606 | BC-5D Hematology Control | R&D Systems, Inc. | Sep 1, 2016 | SESE |
| K141964 | XN CHECK | Streck | Dec 5, 2014 | SESE |
| K141957 | XN CHECK BF | Streck | Dec 5, 2014 | SESE |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | R&D Systems, Inc. | Jul 24, 2013 | SESE |
| K120744 | XN CHECK BF | Streck | Oct 19, 2012 | SESE |
| K120742 | XN CHECK | Streck | Oct 19, 2012 | SESE |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | R&D Systems, Inc. | Apr 28, 2011 | SESE |
| K100790 | COULTER LIN-X LINEARITY CONTROL, MODEL A81196 | Beckman Coulter, Inc. | Dec 21, 2010 | SESE |
| K100607 | COULTER 4C-EX 300 CELL CONTROL | Beckman Coulter, Inc. | Nov 18, 2010 | SESE |
| K091303 | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV | Bio-Rad Laboratories | Aug 2, 2010 | SESE |
| K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL | R&D Systems, Inc. | Jan 29, 2010 | SESE |
| K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL | R&D Systems, Inc. | Oct 28, 2009 | SESE |
| K090201 | UA-CELLULAR FOR IQ | Streck | Mar 27, 2009 | SESE |
| K082162 | COULTER BODY FLUID CONTROL | Beckman Coulter, Inc. | Feb 3, 2009 | SESE |
| K081822 | COULTER 6C CELL CONTROL, MODELS 628027 & A59925 | Beckman Coulter, Inc. | Jan 21, 2009 | SESE |
| K081641 | COULTER LIN-X LINEARITY CONTROL | Beckman Coulter, Inc. | Jan 16, 2009 | SESE |
| K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 | R&D Systems, Inc. | Dec 27, 2007 | SESE |
Top Applicants
- R&D Systems, Inc. — 45 clearances
- Streck Laboratories, Inc. — 23 clearances
- Streck — 12 clearances
- Beckman Coulter, Inc. — 10 clearances
- Coulter Electronics, Inc. — 8 clearances
