510(k) · Cleared
ClearedHscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Enzymes, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on May 18, 2001 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- May 18, 2001
- Review
- 31 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011169 | Hscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3 | International Enzymes, Inc. | 2001 | — |
| +1 | K050836 | CRP Diagnostic Assay | Sentinel Ch. Srl | 2005 | — |
| +2 | K192118 | CRP Vario | SENTINEL CH. SpA | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K050836 | CRP Diagnostic Assay | 2005 | 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?
- Of its descendants, K050836 (Sentinel Ch. Srl, 2005) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K011169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011169: Hscrp Control Level 1, Hscrp Control Level 2, and Hscrp Control Level 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011169
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026