Captiam Syphilis-G Assay
FDA 510(k) K014233 · Trinity Biotech, Plc
510(k) numberK014233
Submission
- Device name
- Captiam Syphilis-G Assay
- Applicant
- Trinity Biotech, Plc
Co. Wicklow, IE - Received
- December 26, 2001
- Decision date
- January 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241427 | Access SyphilisLIP · Traditional | Beckman Coulter, Inc. | 09/06/2024SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | Ortho Clinical Diagnostics | 08/28/2024SE |
| 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 |
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| K033059 | Herpes Group IggLGC · Traditional | 11/26/2003SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | 11/08/2001SE |
| K001525 | Captia Syphilis-G Elisa Test SystemLIP · Traditional | 11/29/2000SE |
| K991697 | Uni-Gold H. PyloriLYR · Traditional | 12/21/1999SE |
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Questions and answers
When was Captiam Syphilis-G Assay cleared by the FDA?
Captiam Syphilis-G Assay (K014233) received a 510(k) decision of Substantially Equivalent on January 24, 2002, 29 days after the submission was received.
What is the product code of K014233?
The FDA product code is LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, a Class II (moderate risk) device regulated under 21 CFR 866.3830.