K201438 is an FDA 510(k) clearance for the ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer. This device is classified as a Antigens, Nontreponemal, All (Class II - Special Controls, product code GMQ).
Submitted by Arlington Scientific, Inc. (Asi) (Springville, US). The FDA issued a Cleared decision on October 21, 2020, 142 days after receiving the submission on June 1, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3820.
| 510(k) Number | K201438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2020 |
| Decision Date | October 21, 2020 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GMQ — Antigens, Nontreponemal, All |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3820 |