510(k) · Cleared
ClearedASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arlington Scientific, Inc. (Asi) · GMQ Antigens, Nontreponemal, All
Cleared on Oct 21, 2020 as substantially equivalent to K173376 (Arlington Scientific, Inc. (Asi), 2018) and 1 other predicate after a 142-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Oct 21, 2020
- Review
- 142 days
- Class
- Class II
- Product code
- GMQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K851504 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK851504 VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985
- 1 generation backK173376 ASI EvolutionArlington Scientific, Inc. (Asi) · 2018
- This deviceK201438 ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use…Arlington Scientific, Inc. (Asi) · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851504 | VDRL Carbon Antigen Test S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | 1985 | — |
| −1 | K173376 | ASI Evolution | Arlington Scientific, Inc. (Asi) | 2018 | — |
| 0 (this device) | K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI… | Arlington Scientific, Inc. (Asi) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GMQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GMQ device
- #1 K250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid…score 10.8 · 3 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173376 | ASI EvolutionSummary page 4…ion: Class II Product Code: GMQ Panel: Microbiology 5.3 Predicate Device(s) – ASI RPR Card Test for Syphilis on the ASI Evolution (K173376, BK170114, and K182391) Device Similarities and Differences Item… | 2018 |
| Kept off the family tree | K170114 | FDA’s K170114 is MagVita TMS Therapy - w/MagPro R20 The summary prints BK170114, a CBER number, which our reading took as K170114, FDA’s number for MagVita TMS Therapy - w/MagPro R20 (Tonica Elektronik A/S). Its FDA name has none of the distinctive words the summary uses for the device it names, “ASI RPR Card Test for Syphilis on the ASI Evolution”. Kept off the family tree. Summary page 4…II Product Code: GMQ Panel: Microbiology 5.3 Predicate Device(s) – ASI RPR Card Test for Syphilis on the ASI Evolution (K173376, BK170114, and K182391) Device Similarities and Differences Item ASI… | 2017 |
| * | K182391 | ASI Automated ASI RPR Test for Syphilis on the ASI EvolutionSummary page 4…Product Code: GMQ Panel: Microbiology 5.3 Predicate Device(s) – ASI RPR Card Test for Syphilis on the ASI Evolution (K173376, BK170114, and K182391) Device Similarities and Differences Item ASI Evolution (N… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 2 companies; a new generation was cleared every 32.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GMQ devicesGMQ Antigens, Nontreponemal, All: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GMQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GMQ
Too few GMQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GMQ
No recall names GMQ since 2007.
Adverse event reports per year · GMQ
2in 2024
MAUDE reports naming product code GMQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Analyzer, is a qualitative and semiquantitative flocculation test for the detection of nontreponemal antibodies in human serum and plasma to aid in the diagnosis of syphilis. All reactive RPR test samples should be further tested with a treponemal test to determine serological evidence of syphilis infection. The test is intended to be used for in vitro diagnostic testing.
The ASI Automated RPR Test for Syphilis is for professional use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201438: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201438
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026