Definition: Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
| Device Type ID | 653 |
| Device Name | Hemoglobin A1c Test System |
| Physical State | In-Vitro Diagnostic Reagent Kit |
| Technical Method | Assay Detecting Glycated Hemoglobin |
| Target Area | Whole Blood |
| Regulation Description | Hemoglobin A1c Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1373 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 653 |
| Device | Hemoglobin A1c Test System |
| Product Code | PDJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemoglobin A1c Test System. |
| CFR Regulation Number | 862.1373 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALERE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARKRAY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER IRELAND INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ROCHE DIAGNOSTICS OPERATIONS (RDO) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEBIA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TOSOH CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Patient Data Problem | 1 |
High Test Results | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Roche Diagnostics Operations, Inc. | II | Nov-11-2016 |