Syphilis Health Check
FDA 510(k) K102400 · Diagnostics Direct, LLC
510(k) numberK102400
Submission
- Device name
- Syphilis Health Check
- Applicant
- Diagnostics Direct, LLC
East Stroudsburg, PA, US - Received
- August 24, 2010
- Decision date
- August 1, 2011
- 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 |
| 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 |
| K102283 | Zeus Scientific, Inc. Treponema Pallidum Igg Test SystemLIP · Traditional | Zeus Scientific, Inc. | 02/10/2011SE |
Questions and answers
When was Syphilis Health Check cleared by the FDA?
Syphilis Health Check (K102400) received a 510(k) decision of Substantially Equivalent on August 1, 2011, 342 days after the submission was received.
What is the product code of K102400?
The FDA product code is LIP – Enzyme Linked Immunoabsorption Assay, Treponema Pallidum, a Class II (moderate risk) device regulated under 21 CFR 866.3830.