Alinity i Toxo IgM
FDA 510(k) clearance K233932 · decided 2024-08-30
Clearance details
- K-number
- K233932
- Device name
- Alinity i Toxo IgM
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2023-12-14
- Decision date
- 2024-08-30
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- LGD
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access Toxo IgG (K242022) | Beckman Coulter, Inc. | 2025-03-28 |
| Access Toxo IgM II (K242095) | Beckman Coulter, Inc. | 2024-10-11 |
| ARCHITECT Toxo IgG (K210596) | Abbott Laboratories | 2022-05-19 |
| Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (K162678) | Roche Diagnostics | 2017-06-23 |
| ADVIA Centaur Toxoplasma M (Toxo M) (K142826) | Siemens Healthcare Diagnostics, Inc. | 2015-12-22 |
| LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234) | DiaSorin, Inc. | 2013-08-28 |
| LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441) | DiaSorin, Inc. | 2013-08-09 |
| VIDAS TOXO IGG AVIDITY (K101946) | bioMerieux, Inc. | 2011-05-18 |
| ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) (K102681) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 |
| PLATELIA TOXO IGM KIT MODEL 26211 (K090847) | Bio-Rad Laboratories | 2009-07-01 |
| ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501) | Roche Diagnostics Corp. | 2008-06-09 |
| ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC (K080869) | Beckman Coulter, Inc. | 2008-05-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |