510(k) · Cleared
ClearedGold Standard Diagnostics 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 · GMQ Antigens, Nontreponemal, All
Cleared on Nov 12, 2015 as substantially equivalent to K111356 (Arlington Scientific, Inc., 2011) after a 273-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Nov 12, 2015
- Review
- 273 days
- Class
- Class II
- Product code
- GMQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851504 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK851504 VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985
- 1 generation backK111356 Asimanager - atArlington Scientific, Inc. · 2011
- This deviceK150358 Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics · 2015
- Descendant · cites it directly · 0 of its ownK250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC · 2025 · cites it directly0descendants
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 | K111356 | Asimanager - at | Arlington Scientific, Inc. | 2011 | — |
| 0 (this device) | K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test… | Gold Standard Diagnostics | 2015 | — |
| +1 | K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated… | Gold Standard Diagnostics, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 10.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K111356 | Asimanager - atSummary page 4…MQ 3) Legally Marketed Device to Which the Submitter Claims Equivalence: Arlington Scientific Inc. (ASI) RPR Card Test for syphilis on the ASiManager-AT Analyzer (K111356). 4) Description of the Device: The Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System in a… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | 2025 | 0 |
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 30 years and passes through 3 companies; a new generation was cleared every 26.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250249 (Gold Standard Diagnostics, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GMQ devicesGMQ Antigens, Nontreponemal, All: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150358: Gold Standard Diagnostics 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/K150358
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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