ACCESS THYROGLOBULIN ANITBODY
FDA 510(k) clearance K112933 · decided 2011-12-27
Clearance details
- K-number
- K112933
- Device name
- ACCESS THYROGLOBULIN ANITBODY
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-03
- Decision date
- 2011-12-27
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- JNL
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816) | Siemens Healthcare Diagnostics, Inc. | 2025-12-04 |
| Access Thyroglobulin Antibody II (K240996) | Beckman Coulter, Inc. | 2024-07-03 |
| IMMUNOCAP THYRLOBULIN IMMUNOCAP (K072661) | Phadia US, Inc. | 2007-11-20 |
| ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516) | Beckman Coulter, Inc. | 2006-10-05 |
| ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (K971834) | Monobind | 1997-07-03 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (K962451) | Hycor Biomedical, Inc. | 1996-11-25 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (K962341) | Hycor Biomedical, Inc. | 1996-11-25 |
| ANTI-TPO (K954256) | Biomerica, Inc. | 1995-11-27 |
| THYROGLOBULIN EIA TEST KIT (K951362) | Immunoprobe, Inc. | 1995-11-20 |
| MICROSOMAL EIA TEST KIT (K951364) | Immunoprobe, Inc. | 1995-11-20 |
| AURAFLEX TG-AB AND TPO-AB (K951320) | Organon Teknika Corp. | 1995-08-25 |
| AURAFLEX TPO-AB (K952607) | Organon Teknika Corp. | 1995-08-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14 recall (Z-0265-2025) | Beckman Coulter, Inc. | 2024-10-30 |
| Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 ( recall (Z-2242-2020) | Beckman Coulter Inc. | 2020-06-02 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |