Elecsys Tg II
FDA 510(k) clearance K221890 · decided 2023-09-30
Clearance details
- K-number
- K221890
- Device name
- Elecsys Tg II
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2022-06-29
- Decision date
- 2023-09-30
- Days to decision
- 458 days
- Clearance type
- Traditional
- Product code
- MSW
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, 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 |
| 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 |
| ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER (K002905) | Beckman Coulter, Inc. | 2000-10-19 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |