510(k) · Cleared
ClearedQuantex Aso-CRP-RP Control II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JJT Enzyme Controls (Assayed And Unassayed)
Cleared on Feb 2, 1999 as substantially equivalent to K971777 (Instrumentation Laboratory CO, 1997) after a 50-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Feb 2, 1999
- Review
- 50 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K894486 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894486 | Quantex Aso Plus (Latex,Buffer Standard,Control) | Biokit USA, Inc. | 1989 | — |
| −1 | K971777 | Quantex Aso-CRP-RF Control | Instrumentation Laboratory CO | 1997 | — |
| 0 (this device) | K984437 | Quantex Aso-CRP-RP Control II | Instrumentation Laboratory CO | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 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 JJT? 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 |
|---|---|---|---|
| * | K971777 | Quantex Aso-CRP-RF ControlSummary page 1…device: . quantex ASO-CRP-RF control II Classification name(s): 862.1660 Quality Control Material (Assayed and Unassayed) Class | Identification of predicate devices: K971777 quantex ASO-CRP-RF control Description of the device/intended use(s): The quantex ASO-CRP-RF control I is an in vitro diagnosti… | 1997 |
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 10 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JJT devicesJJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJT
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JJT
Too few JJT 510(k)s in any year since 2007 to give a median.
Recalls per year · JJT
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJT
1in 2011
MAUDE reports naming product code JJT, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.
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/K984437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984437: Quantex Aso-CRP-RP Control II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984437
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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