ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
FDA 510(k) clearance K002905 · decided 2000-10-19
Clearance details
- K-number
- K002905
- Device name
- ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-18
- Decision date
- 2000-10-19
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- MSW
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, 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 |
|---|---|---|
| Atellica IM Thyroglobulin (Tg) (K242981) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 |
| Access Thyroglobulin (K240927) | Beckman Coulter, Inc. | 2024-06-28 |
| Access Thyroglobulin (K241423) | Beckman Coulter, Inc. | 2024-06-07 |
| Elecsys Tg II (K221890) | Roche Diagnostics | 2023-09-30 |
| Access Thyroglobulin (K220972) | Beckman Coulter, Inc. | 2023-09-15 |
| ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (K031269) | Beckman Coulter, Inc. | 2003-05-02 |
| BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS (K021057) | Brahms Diagnostica, LLC | 2002-09-17 |
| NICHOLS ADVANTAGE THYROGLOB (K002888) | Nichols Institute Diagnostics | 2000-10-20 |
| NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 (K994140) | Nichols Institute Diagnostics | 2000-05-09 |
| KRONUS OPTIQUANT THYROGLOBULIN KIT (K991720) | Unchanged | 1999-08-09 |
| IMMULITE THYROGLOBULIN MODEL LKTY (K982466) | Diagnostic Products Corp. | 1999-03-12 |
| IMMULITE 2000 THYROGLOBULIN MODEL L2KTY (K982468) | Diagnostic Products Corp. | 1999-03-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590 recall (Z-2240-2020) | Beckman Coulter Inc. | 2020-06-02 |
| Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitati recall (Z-2733-2015) | Beckman Coulter Inc. | 2015-09-03 |
| Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to ai recall (Z-2215-2011) | Beckman Coulter Inc. | 2011-05-19 |
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 |