510(k) · Cleared
ClearedQuantex Aso-CRP-RF Control
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 May 27, 1997 as substantially equivalent to K894486 (Biokit USA, Inc., 1989) and 2 other predicates after a 13-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- May 27, 1997
- Review
- 13 days
- Class
- Class I
- Product code
- JJT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K894486 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK894486 Quantex Aso Plus (Latex,Buffer Standard,Control)Biokit USA, Inc. · 1989
- This deviceK971777 Quantex Aso-CRP-RF ControlInstrumentation Laboratory CO · 1997
- Descendant · cites it directly · 0 of its ownK984437 Quantex Aso-CRP-RP Control IIInstrumentation Laboratory CO · 1999
Most influential descendants
Showing 1 of 1 · See all- K984437Quantex Aso-CRP-RP Control IIInstrumentation Laboratory CO · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894486 | Quantex Aso Plus (Latex,Buffer Standard,Control) | Biokit USA, Inc. | 1989 | — |
| 0 (this device) | K971777 | Quantex Aso-CRP-RF Control | Instrumentation Laboratory CO | 1997 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K894486 | Quantex Aso Plus (Latex,Buffer Standard,Control)Summary page 1…CRP-RF control Classification name(s): 862.1660 Quality Control Material (Assayed and Unassayed) Class I Identification of predicate devices: quantex ASO plus control K894486 quantex CRP plus contro] K896272 quantex RF plus control K896271 Description of the device/intended use(s): Biokit’s ASO-CRP-RF… | 1989 |
| * | K896272 | Quantex CRP Plus (Latex, Buffer, Standard, ControlSummary page 1…me(s): 862.1660 Quality Control Material (Assayed and Unassayed) Class I Identification of predicate devices: quantex ASO plus control K894486 quantex CRP plus contro] K896272 quantex RF plus control K896271 Description of the device/intended use(s): Biokit’s ASO-CRP-RF control is an in vitro diagnosti… | 1989 |
| * | K896271 | Quantex RF Plus (Latex, Buffer Standard, Control)Summary page 1…Material (Assayed and Unassayed) Class I Identification of predicate devices: quantex ASO plus control K894486 quantex CRP plus contro] K896272 quantex RF plus control K896271 Description of the device/intended use(s): Biokit’s ASO-CRP-RF control is an in vitro diagnostic product intended for use with… | 1989 |
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 |
|---|---|---|---|
| K984437 | Quantex Aso-CRP-RP Control II | 1999 | 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K984437 (Instrumentation Laboratory CO, 1999) has gone furthest, with 0 descendants of its own.
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?
Biokit’s ASO-CRP-RF control 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/K971777 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971777: Quantex Aso-CRP-RF Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971777
Report an extraction error
Are you the manufacturer?
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