510(k) · Cleared
ClearedAsimanager - at
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arlington Scientific, Inc. · JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Cleared on Nov 9, 2011 as substantially equivalent to K851504 (Ncs Diagnostics, Inc., 1985) after a 177-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Nov 9, 2011
- Review
- 177 days
- Class
- Class I
- Product code
- JQT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851504 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK851504 VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985
- This deviceK111356 Asimanager - atArlington Scientific, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK150358 Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics · 2015
- Descendant · 2 generations on · 0 of its ownK250249 Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR)…Gold Standard Diagnostics, LLC · 2025
Most influential descendants
Showing 2 of 2 · See all- K150358Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics · 2015 · cites it directly1descendant
- K250249Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGold Standard Diagnostics, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851504 | VDRL Carbon Antigen Test S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | 1985 | — |
| 0 (this device) | K111356 | Asimanager - at | Arlington Scientific, Inc. | 2011 | — |
| +1 | K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test… | Gold Standard Diagnostics | 2015 | — |
| +2 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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 JQT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K851504 | VDRL Carbon Antigen Test S900500, S900250 & S90010Summary page 1…scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. 5.3 Predicate Device(s) - ASI RPR Card Test for Syphilis - K851 504 5.4 Device Description - The ASiManager-AT is an integrated digital particle analyzer designed to o… | 1985 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | 2015 | 1 |
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?
How does its category compare?
All JQT devicesJQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JQT
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · JQT
Too few JQT 510(k)s in any year since 2007 to give a median.
Recalls per year · JQT
No recall names JQT since 2007.
Adverse event reports per year · JQT
5in 2025
MAUDE reports naming product code JQT, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111356: Asimanager - at.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111356
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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