The Daya Syphilis Test/The Trust Antigen Test
FDA 510(k) K000687 · Beacon Biologicals, Inc.
510(k) numberK000687
Submission
- Device name
- The Daya Syphilis Test/The Trust Antigen Test
- Applicant
- Beacon Biologicals, Inc.
Boca Raton, FL, US - Received
- February 29, 2000
- Decision date
- June 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GMQ – Antigens, Nontreponemal, All
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3820
- Specialty
- Microbiology
Other 510(k)s with product code GMQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics, LLC | 10/10/2025SE |
| K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…GMQ · Traditional | Arlington Scientific, Inc. (Asi) | 10/21/2020SE |
| K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionGMQ · Traditional | Arlington Scientific, Inc. (Asi) | 11/30/2018SE |
| K173376 | ASI EvolutionGMQ · Traditional | Arlington Scientific, Inc. (Asi) | 06/14/2018SE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics | 11/12/2015SE |
| K993633 | Synthetic VDRL AntigenGMQ · Traditional | Centers for Disease Control and Prevention | 02/23/2000SE |
| K992124 | Avanti Polar Lipids VDRL Antigen Slide Test Kit with 10 X 0.5 ML Ampules, Avanti Polar…GMQ · Traditional | Avanti Polar Lipids, Inc. | 09/20/1999SE |
| K954994 | TrustGMQ · Traditional | Guardian Scientific, Corp. | 10/18/1996SE |
| K955136 | RPR Card Test KitGMQ · Traditional | Remel, L.P. | 07/29/1996SE |
| K952802 | Visuwell Reagin IIGMQ · Traditional | Biomira Diagnostics, Inc. | 05/23/1996SE |
Questions and answers
When was The Daya Syphilis Test/The Trust Antigen Test cleared by the FDA?
The Daya Syphilis Test/The Trust Antigen Test (K000687) received a 510(k) decision of Substantially Equivalent on June 12, 2000, 104 days after the submission was received.
What is the product code of K000687?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.