System, Hemoglobin, Automated
FDA product code GKR · Class II (moderate risk) · 21 CFR 864.5620 · Hematology
39510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Hemocue, Inc. 6
- Ekf-Diagnostic GmbH 4
- Stanbio Laboratory 3
- Hematology Marketing Assoc. 2
- Immunostics Inc., 2
- Helena Laboratories 2
- King Diagnostics, Inc. 1
- Omega Medical Diagnostics 1
- Aktiebolaget Leo Diagnostics 1
- Medical Specialties, Inc. 1
- J.T. Baker Chemical Co. 1
- Diversa Corp. 1
- Clearview Instruments, Inc. 1
- Ciba Corning Diagnostics Corp. 1
- Toa Medical Electronics USA, Inc. 1
- R&D Systems, Inc. 1
- Instrumentation Laboratory CO 1
- Sysmex Corp. 1
- Bayer Diagnostics Corp. 1
- Innovative Medical Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | Hemocue AB | 08/04/2020SE |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM)GKR · Special | Ekf-Diagnostic GmbH | 06/12/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | Hemocue AB | 02/01/2019SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 11/16/2018SE |
| K172173 | DiaSpect Tm, DiaSpect Tm CuvettesGKR · Traditional | Ekf-Diagnostic GmbH | 04/06/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 09/08/2017SE |
| K122553 | Mission Plus HB Hemoglobin Testing SystemGKR · Traditional | ACON Laboratories, Inc. | 08/05/2013SE |
| K121752 | Avie Total HB Test SystemGKR · Traditional | Mec Dynamics Corp | 01/07/2013SE |
| K110393 | Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special | Ekf-Diagnostic GmbH | 03/04/2011SE |
| K090093 | Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special | Stanbio Laboratory | 06/10/2009SE |
| K081719 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Special | Stanbio Laboratory | 07/18/2008SE |
| K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801GKR · Traditional | Hemocue AB | 06/08/2006SE |
| K041234 | Hemocue Hemoglobin 201DM Analyzing SystemGKR · Special | Hemocue, Inc. | 06/10/2004SE |
| K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Traditional | Stanbio Laboratory | 10/24/2003SE |
| K031898 | Ekf Diagnostic Hemo Control Hemoglobin Measurement SystemGKR · Traditional | Ekf Diagnostic GmbH | 09/24/2003SE |
| K032203 | Hemocue Hemoglobin 201 + System Article 121704GKR · Special | Hemocue, Inc. | 08/25/2003SE |
| K023561 | Itc HGB Pro Professional Hemoglobin Testing SystemGKR · Traditional | International Technidyne Corp. | 01/31/2003SE |
| K020710 | Biotest Hemoglobin Measuring SystemGKR · Abbreviated | Biotest Medizintechnik GmbH | 08/14/2002SE |
| K020616 | Bayer Rapidpoint 405 SystemGKR · Traditional | Bayer Diagnostics Corp. | 07/17/2002SE |
| K961312 | Hemocue B-Hemoglobin SystemGKR · Traditional | Hemocue, Inc. | 09/24/1996SE |
| K945677 | IL682, Co-OximeterGKR · Traditional | Instrumentation Laboratory CO | 10/20/1995SE |
| K954018 | Avl Omni AnalyzerGKR · Traditional | Avl Scientific Corp. | 10/05/1995SE |
| K910745 | Hemoglobin ReagentGKR · Traditional | Toa Medical Electronics USA, Inc. | 07/11/1991SE |
| K880353 | Ciba Corning Model 280 Ph/Blood Gas SystemGKR · Traditional | Ciba Corning Diagnostics Corp. | 06/15/1988SE |
| K870210 | Clearview CW-10GKR · Traditional | Clearview Instruments, Inc. | 04/28/1987SE |
| K865055 | Dr.Bruno Lange MINI-HBA1 PhotometerGKR · Traditional | Diversa Corp. | 03/19/1987SE |
| K850096 | Laser-GlobinGKR · Traditional | Hematology Marketing Assoc. | 03/29/1985SE |
| K850094 | Laser-Globin PowderGKR · Traditional | Hematology Marketing Assoc. | 03/29/1985SE |
| K841057 | Hemoglobin Reagent SetGKR · Traditional | Medical Specialties, Inc. | 03/23/1984SE |
| K832020 | Hemocue Photometer Technical ManualGKR · Traditional | Aktiebolaget Leo Diagnostics | 10/28/1983SE |
| K831618 | Hemoglobin ReagentGKR · Traditional | Omega Medical Diagnostics | 06/16/1983SE |
| K812127 | King Diagnostics Hemoglobin TestGKR · Traditional | King Diagnostics, Inc. | 08/25/1981SE |
| K803016 | Helena Hemespec II Total Hemoglobin Met.GKR · Traditional | Helena Laboratories | 12/30/1980SE |
| K803015 | Hemespec IIGKR · Traditional | Helena Laboratories | 12/30/1980SE |
| K802266 | HGB3 (1:251)GKR · Traditional | R&D Systems, Inc. | 10/23/1980SE |
| K790030 | Fluid, Rhemox-Hb LysingGKR · Traditional | Sysmex Corp. | 02/08/1979SE |
| K781361 | Hemoglobinometer Model 720 BGKR · Traditional | Innovative Medical Systems, Inc. | 09/14/1978SE |
| K780829 | Sysing and Hemoglobin ReagentGKR · Traditional | Harleco | 06/22/1978SE |
| K771789 | Blanking Solution HGBGKR · Traditional | J.T. Baker Chemical Co. | 10/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2930-2018 Class II | RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care…Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox… | Siemens Healthcare Diagnostics, Inc. | 07/16/2018Terminated |
| Z-2929-2018 Class II | RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care…Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox… | Siemens Healthcare Diagnostics, Inc. | 07/16/2018Terminated |
| Z-2928-2018 Class II | RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is…Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox… | Siemens Healthcare Diagnostics, Inc. | 07/16/2018Terminated |
| Z-2927-2018 Class II | RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999…Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox… | Siemens Healthcare Diagnostics, Inc. | 07/16/2018Terminated |
| Z-2926-2018 Class II | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name…The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing… | Stanbio Laboratory, LP | 02/08/2018Terminated |
| Z-0101-2014 Class II | HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB…HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes… | HemoCue AB | 07/25/2013Terminated |
| Z-1854-2011 | HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100…ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips… | ITC-Nexus Dx, Inc. | 01/21/2011Terminated |
| Z-1849-2011 | HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin…Incorrect configurations settings in software. As a result, certain error codes do not trigger… | Hemo Cue, Inc. | 10/07/2010Terminated |