510(k) · Cleared
ClearedApolipoprotein Control Serum CHD, Model Ouph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Nov 30, 1999 after a 57-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Nov 30, 1999
- Review
- 57 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 2 citing it directly.
- This deviceK993310 Apolipoprotein Control Serum CHD, Model OuphDade Behring, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK063608 Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1…Dade Behring, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK181373 Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018
- Descendant · cites it directly · 0 of its ownK042521 Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits…Ortho-Clinical Diagnostics, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See all- K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…Dade Behring, Inc. · 2007 · cites it directly1descendant
- K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018 · 2 generations on0descendants
- K042521Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1…Ortho-Clinical Diagnostics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993310 | Apolipoprotein Control Serum CHD, Model Ouph | Dade Behring, Inc. | 1999 | — |
| +1 | K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1… | Dade Behring, Inc. | 2007 | — |
| +2 | K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | 2018 | — |
| +1 | K042521 | Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22… | Ortho-Clinical Diagnostics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2018 | 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 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K903687 | FDA’s K903687 is Turbiquant Myoglobin Our OCR of the scanned summary read K903687, FDA’s number for Turbiquant Myoglobin (Behring Diagnostics, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Apolipoprotein Control Serum”. Kept off the family tree. Summary page 1…e: September 30, 1999 Device Name / Classification: Apolipoprotein Control Serum CHD Quality Control Material (assayed) Predicate Device: Apolipoprotein Control Serum (K903687) Device Description: Apolipoprotein Control Serum CHD is a lyophilized reagent prepared from human serum with stabilizers and pr… | 1990 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K063608 (Dade Behring, Inc., 2007) 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 | — |
What is it indicated for?
Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of Apolipoprotein A-l and B by radial immunodiffusion;
Apolipoprotein A-l, All*, B, E* and CRP with the Behring Nephelometer Systems;
and Apolipoprotein A-l, B and Myoglobin with the TurbiTime System™
* Reagents for these determinations are not available in USA
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/K993310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993310: Apolipoprotein Control Serum CHD, Model Ouph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993310
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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