Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k) K250249 · Gold Standard Diagnostics, LLC
510(k) numberK250249
Submission
- Device name
- Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- Applicant
- Gold Standard Diagnostics, LLC
Davis, CA, US - Received
- January 27, 2025
- Decision date
- October 10, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K000687 | The Daya Syphilis Test/The Trust Antigen TestGMQ · Traditional | Beacon Biologicals, Inc. | 06/12/2000SE |
| 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 |
More from Biomira Diagnostics, Inc.
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| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | 05/02/2018SE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | 11/12/2015SE |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa TestMXJ · Traditional | 02/28/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | 01/28/2014SE |
Questions and answers
When was Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System cleared by the FDA?
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K250249) received a 510(k) decision of Substantially Equivalent on October 10, 2025, 256 days after the submission was received.
What is the product code of K250249?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.