510(k) · Cleared
ClearedGold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Diagnostics, LLC · GMQ Antigens, Nontreponemal, All
Cleared on Oct 10, 2025 as substantially equivalent to K150358 (Gold Standard Diagnostics, 2015) after a 256-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Oct 10, 2025
- Review
- 256 days
- Class
- Class II
- Product code
- GMQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851504 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK851504 VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985
- 2 generations backK111356 Asimanager - atArlington Scientific, Inc. · 2011
- 1 generation backK150358 Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics · 2015
- This deviceK250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851504 | VDRL Carbon Antigen Test S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | 1985 | — |
| −2 | K111356 | Asimanager - at | Arlington Scientific, Inc. | 2011 | — |
| −1 | K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test… | Gold Standard Diagnostics | 2015 | — |
| 0 (this device) | K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated… | Gold Standard Diagnostics, LLC | 2025 | — |
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 K201438 ASI Automated RPR (rapid plasma reagin) Test…score 0.5 · 2 generations · no Class I recall
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemSummary page 5…ode: GMQ 3) Legally Marketed Device to Which the Submitter Claims Equivalence: Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System (K150358). 4) Description of the Device: The Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System… | 2015 |
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 40 years and passes through 4 companies; a new generation was cleared every 9.9 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. 2025, 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 Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is a non-treponemal flocculation test that can qualitatively determine the presence of reagin antibodies in human serum, automated on the AIX1000 Analyzer. It may be used to aid in the diagnosis of syphilis when used in conjunction with supplemental treponemal laboratory tests and other clinical information. This test may also be used to detect non-treponemal antibodies in samples serially diluted to establish titer information. This test is not intended for screening blood or tissue donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250249: Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250249
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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