Access Toxo IgM II
FDA 510(k) K242095 · Beckman Coulter, Inc.
510(k) numberK242095
Submission
- Device name
- Access Toxo IgM II
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- July 17, 2024
- Decision date
- October 11, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LGD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242022 | Access Toxo IgGLGD · Traditional | Beckman Coulter, Inc. | 03/28/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | Abbott Laboratories | 08/30/2024SE |
| K210596 | ARCHITECT Toxo IgGLGD · Traditional | Abbott Laboratories | 05/19/2022SE |
| K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlLGD · Traditional | Roche Diagnostics | 06/23/2017SE |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M)LGD · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/22/2015SE |
| K132234 | Liaison(R) Toxo Igg II, Liaison(R) Control Toxo Igg IILGD · Traditional | DiaSorin, Inc. | 08/28/2013SE |
| K131441 | Liaison Toxo Igm II, Liaison Control Toxo Igm IILGD · Traditional | DiaSorin, Inc. | 08/09/2013SE |
| K101946 | Vidas Toxo Igg AvidityLGD · Traditional | bioMerieux, Inc. | 05/18/2011SE |
| K102681 | Advia Centaur Toxoplasma Igg (Toxo G)LGD · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/04/2011SE |
| K090847 | Platelia Toxo Igm Kit Model 26211LGD · Special | Bio-Rad Laboratories | 07/01/2009SE |
More from Bio-Rad Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access Toxo IgM II cleared by the FDA?
Access Toxo IgM II (K242095) received a 510(k) decision of Substantially Equivalent on October 11, 2024, 86 days after the submission was received.
What is the product code of K242095?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.