VITROS Immunodiagnostic Products Syphilis Reagent Pack
FDA 510(k) K241534 · Ortho Clinical Diagnostics
510(k) numberK241534
Submission
- Device name
- VITROS Immunodiagnostic Products Syphilis Reagent Pack
- Applicant
- Ortho Clinical Diagnostics
Bridgend, GB - Received
- May 30, 2024
- Decision date
- August 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Specialty
- Microbiology
Other 510(k)s with product code LIP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241427 | Access SyphilisLIP · Traditional | Beckman Coulter, Inc. | 09/06/2024SE |
| K211302 | Elecsys SyphilisLIP · Traditional | Roche Diagnostics | 07/20/2021SE |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…LIP · Traditional | Bio-Rad Laboratories | 05/11/2017SE |
| K160910 | Elecsys SyphilisLIP · Traditional | Roche Diagnostics | 07/28/2016SE |
| K153145 | Lumipulse G TP-N Immunoreaction Cartridge SetLIP · Traditional | Fujirebio Diagnostics,Inc. | 07/05/2016SE |
| K153730 | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP…LIP · Traditional | Abbott Laboratories | 06/15/2016SE |
| K120439 | Bioplex 2200 Ebv Igg and Syphilis IggLIP · Special | Bio-Rad Laboratories, Inc. | 03/14/2012SE |
| K112343 | Treponema Pallidum Treponemal Test Reagents; Quality Control MaterialsLIP · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/20/2012SE |
| K102400 | Syphilis Health CheckLIP · Traditional | Diagnostics Direct, LLC | 08/01/2011SE |
| K102283 | Zeus Scientific, Inc. Treponema Pallidum Igg Test SystemLIP · Traditional | Zeus Scientific, Inc. | 02/10/2011SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | 08/23/2023SE |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | 10/04/2021SE |
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | 08/13/2021SE |
Questions and answers
When was VITROS Immunodiagnostic Products Syphilis Reagent Pack cleared by the FDA?
VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534) received a 510(k) decision of Substantially Equivalent on August 28, 2024, 90 days after the submission was received.
What is the product code of K241534?
The FDA product code is LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, a Class II (moderate risk) device regulated under 21 CFR 866.3830.