| Device Type ID | 2411 |
| Device Name | Assay, Glycosylated Hemoglobin |
| Regulation Description | Glycosylated Hemoglobin Assay. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LCP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2411 |
| Device | Assay, Glycosylated Hemoglobin |
| Product Code | LCP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Glycosylated Hemoglobin Assay. |
| CFR Regulation Number | 864.7470 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALERE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASAHI KASEI PHARMA CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EKF-DIAGNOSTIC GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOME ACCESS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOME ACCESS HEALTH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSANG HEALTHCARE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS INDIANAPOLIS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAKAE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SD BIOSENSOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEBIA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAIDOC TECHNOLOGY CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 628 |
Device Operational Issue | 471 |
Device Displays Incorrect Message | 440 |
Device Issue | 317 |
Mechanical Problem | 218 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 125 |
Increase In Pressure | 94 |
High Test Results | 87 |
Incorrect Or Inadequate Test Results | 84 |
Pressure Problem | 72 |
Decrease In Pressure | 60 |
Use Of Device Problem | 56 |
Leak / Splash | 43 |
Device Component Or Accessory | 38 |
Device Ingredient Or Reagent Problem | 33 |
Low Test Results | 30 |
Probe | 17 |
Computer Software Problem | 17 |
Adverse Event Without Identified Device Or Use Problem | 17 |
Fluid Leak | 14 |
Calibration Problem | 13 |
Noise, Audible | 13 |
Printer | 13 |
Connection Problem | 12 |
High Readings | 12 |
Output Problem | 12 |
Failure To Align | 9 |
Break | 9 |
Imprecision | 9 |
Low Readings | 9 |
Obstruction Of Flow | 8 |
Physical Property Issue | 7 |
Occlusion Within Device | 7 |
Complete Blockage | 7 |
No Pressure | 6 |
Device Maintenance Issue | 6 |
Contamination Of Device Ingredient Or Reagent | 5 |
Failure To Calibrate | 5 |
Device Ingredient Or Reagent | 5 |
Bent | 5 |
Image Resolution Poor | 4 |
Fitting Problem | 4 |
Partial Blockage | 4 |
Filter | 4 |
Temperature Problem | 3 |
Insufficient Information | 3 |
Loose Or Intermittent Connection | 3 |
Calibration Error | 3 |
Cell | 3 |
Tube | 3 |
Mechanical Jam | 3 |
Material Integrity Problem | 3 |
Nozzle | 2 |
Issue With Displayed Error Message | 2 |
Loss Of Data | 2 |
Valve | 2 |
Inaccurate Flow Rate | 2 |
Infusion Or Flow Problem | 2 |
Communication Or Transmission Problem | 2 |
No Display / Image | 2 |
Electrical /Electronic Property Problem | 2 |
Non Reproducible Results | 2 |
Computer Operating System Problem | 2 |
Human Factors Issue | 2 |
Pump | 2 |
Inadequate Or Insufficient Training | 2 |
Detachment Of Device Component | 2 |
Poor Quality Image | 2 |
Material Deformation | 2 |
Motor | 1 |
Device Contamination With Biological Material | 1 |
Device Subassembly | 1 |
Reader | 1 |
Cassette | 1 |
Air Leak | 1 |
Loss Of Power | 1 |
Failure To Power Up | 1 |
Material Separation | 1 |
Folded | 1 |
Malposition Of Device | 1 |
Connector | 1 |
CPU (Central Processing Unit) Board | 1 |
Belt | 1 |
Device Alarm System | 1 |
Detachment Of Device Or Device Component | 1 |
Blocked Connection | 1 |
Nonstandard Device | 1 |
Display Or Visual Feedback Problem | 1 |
Pressure Tubing | 1 |
Valve, Flow | 1 |
Gauges/Meters | 1 |
Switches | 1 |
Lamp | 1 |
Syringe | 1 |
Incorrect Measurement | 1 |
Device Difficult To Setup Or Prepare | 1 |
Failure To Recalibrate | 1 |
Delamination | 1 |
Appropriate Term/Code Not Available | 1 |
Seal | 1 |
| Total Device Problems | 3138 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bio-Rad Laboratories, Inc. | II | Jan-27-2016 |
| 2 | Bio-Rad Laboratories, Inc. | II | Mar-27-2014 |
| 3 | Bio-Rad Laboratories, Inc. | III | Feb-10-2014 |
| 4 | Metrika Inc | II | Jun-25-2015 |
| 5 | Randox Laboratories Ltd. | II | Dec-22-2017 |
| 6 | Roche Diagnostics Operations, Inc. | II | Nov-11-2016 |
| 7 | Siemens Healthcare Diagnostics, Inc. | II | Aug-30-2016 |
| 8 | Siemens Healthcare Diagnostics, Inc. | II | Nov-25-2015 |
| 9 | Siemens Healthcare Diagnostics, Inc. | II | Nov-21-2014 |
| 10 | Siemens Healthcare Diagnostics, Inc. | II | Oct-24-2014 |
| 11 | Siemens Healthcare Diagnostics, Inc. | II | Jan-03-2014 |
| 12 | Tosoh Bioscience Inc | III | Dec-13-2018 |
| 13 | Tosoh Bioscience Inc | II | Sep-25-2018 |
| 14 | Tosoh Bioscience Inc | II | Aug-11-2018 |
| 15 | Tosoh Bioscience Inc | II | May-14-2018 |
| 16 | Tosoh Bioscience, Inc. | III | Jul-14-2015 |