JOX · Analyzer, Heparin, Automated
Hematology · 21 CFR 864.5680 · Class 2
Overview
| Product Code | JOX |
|---|---|
| Device Name | Analyzer, Heparin, Automated |
| Regulation | 21 CFR 864.5680 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
Classification Rationale
Class II (special controls).
Special Controls
*Classification.* Class II (special controls).
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K111339 | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | Medtronic, Inc. | Jun 8, 2011 | SESE |
| K102953 | HEPARIN DOSE RESPONSE CARTRIDGE | Medtronic, Inc. | Nov 4, 2010 | SESE |
| K101271 | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | Medtronic, Inc. | Oct 13, 2010 | SESE |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Perfusion Systems | May 24, 2005 | SESE |
| K043080 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Vascular | Dec 3, 2004 | SESE |
| K042070 | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | Medtronic Vascular | Oct 1, 2004 | SESE |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | Cardiovascular Diagnostics, Inc. | Jan 14, 2000 | SESE |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Medtronic Hemotec, Inc. | Jul 21, 1992 | SESE |
| K911240 | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | Hemotech, Inc. | Jul 17, 1991 | SESE |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Hemotec, Inc. | Sep 5, 1989 | SESE |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Hemotec, Inc. | Dec 4, 1985 | SESE |
| K841021 | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | Hemotec, Inc. | May 25, 1984 | SESE |
| K830665 | HEPCOL SYSTEM B-10 & B-10-P | Hemotec, Inc. | Jun 8, 1983 | SESE |
| K813011 | HEPAQUANT | Streck Laboratories, Inc. | Jan 26, 1982 | SESE |
| K800161 | HEPCON/SYSTEM RC-10 | Hemotec, Inc. | Mar 19, 1980 | SESE |
Top Applicants
- Hemotec, Inc. — 5 clearances
- Medtronic, Inc. — 3 clearances
- Medtronic Vascular — 2 clearances
- Cardiovascular Diagnostics, Inc. — 1 clearance
- Hemotech, Inc. — 1 clearance
