ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
FDA 510(k) K201438 · Arlington Scientific, Inc. (Asi)
510(k) numberK201438
Submission
- Device name
- ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
- Applicant
- Arlington Scientific, Inc. (Asi)
Springville, UT, US - Received
- June 1, 2020
- Decision date
- October 21, 2020
- 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 |
|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | Gold Standard Diagnostics, LLC | 10/10/2025SE |
| 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 |
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Questions and answers
When was ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer cleared by the FDA?
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer (K201438) received a 510(k) decision of Substantially Equivalent on October 21, 2020, 142 days after the submission was received.
What is the product code of K201438?
The FDA product code is GMQ – Antigens, Nontreponemal, All, a Class II (moderate risk) device regulated under 21 CFR 866.3820.