Elecsys Anti-HAV II
FDA 510(k) K190428 · Roche Diagnostics
510(k) numberK190428
Submission
- Device name
- Elecsys Anti-HAV II
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- February 22, 2019
- Decision date
- August 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOL – Hepatitis A Test (Antibody And Igm Antibody)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3310
- Specialty
- Microbiology
Other 510(k)s with product code LOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | Roche Diagnostics | 04/07/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | Beckman Coulter, Inc. | 01/27/2026SE |
| K243846 | Access anti-HAVLOL · Traditional | Beckman Coulter, Inc. | 09/09/2025SE |
| K222850 | HAVAb IgG IILOL · Traditional | Abbott Laboratories | 08/10/2023SE |
| K223403 | LIAISON Anti-HAV; LIAISON XSLOL · Special | DiaSorin, Inc. | 12/09/2022SE |
| K210272 | LIAISON Anti-HAVLOL · Special | DiaSorin, Inc. | 02/09/2021SE |
| K193532 | LIAISON Anti-HAV AssayLOL · Traditional | DiaSorin, Inc. | 03/02/2020SE |
| K161964 | ADVIA Centaur HAV IgM AssayLOL · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/13/2016SE |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgMLOL · Traditional | DiaSorin, Inc. | 08/25/2016SE |
| K142758 | ADVIA Centaur HAV total assayLOL · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/05/2014SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Elecsys Anti-HAV II cleared by the FDA?
Elecsys Anti-HAV II (K190428) received a 510(k) decision of Substantially Equivalent on August 13, 2019, 172 days after the submission was received.
What is the product code of K190428?
The FDA product code is LOL – Hepatitis A Test (Antibody And Igm Antibody), a Class II (moderate risk) device regulated under 21 CFR 866.3310.