JPI · Device, Hematocrit Measuring
Hematology · 21 CFR 864.6400 · Class 2
Overview
| Product Code | JPI |
|---|---|
| Device Name | Device, Hematocrit Measuring |
| Regulation | 21 CFR 864.6400 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Feb 28, 2020 | SESE |
| K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories | Aug 22, 2017 | SESE |
| K950942 | CRIT-LINE HEMATOCRIT ALERT | In-Line Diagnostics Corp. | Mar 14, 1995 | SESE |
| K924167 | CRIT-LINE | Noninvasive Medical Technology Corp. | May 7, 1993 | SESE |
| K903698 | STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES | Statspin Technologies | Sep 17, 1990 | SESE |
| K902028 | STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER | Norfolk Scientific, Inc. | Jun 20, 1990 | SESE |
| K870511 | CHART-TYPE MICRO HEMATOCRIT TUBE READER | Norfolk Scientific, Inc. | Mar 16, 1987 | SESE |
| K852516 | CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE | Whittaker General Medical | Jul 15, 1985 | SESE |
| K852482 | MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 | Em Diagnostic Systems, Inc. | Jul 15, 1985 | SESE |
| K850391 | PLASMA EXTRACTION SYSTEM | Hans J. Brouwers & Assoc. | May 10, 1985 | SESE |
| K840767 | HAEMOFUGE A. BIOFUGE A. & B | Heraeus-Christ GmbH | Apr 17, 1984 | SESE |
| K831318 | COMPUR* M1100 HEMATRCRIT SYSTEM | Worthington Diagnostic Systems | Jun 8, 1983 | SESE |
| K830578 | MICROHEMATOCRIT READER | Fisher Scientific Co., LLC | Mar 24, 1983 | SESE |
| K823558 | MICRO-HEMATOCRIT CENTRIFUGE 335/336 | Fisher Scientific Co., LLC | Jan 21, 1983 | SESE |
| K822716 | UNIVERSAL CENTRIFUGE | Biodynamics Corp. | Sep 30, 1982 | SESE |
Top Applicants
- Fisher Scientific Co., LLC — 2 clearances
- Norfolk Scientific, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- Abbott Point of Care, Inc. — 1 clearance
- Biodynamics Corp. — 1 clearance
