510(k) · Cleared
ClearedNormal and Hypergamma Control Serum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sebia · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Apr 28, 2004 after a 20-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 28, 2004
- Review
- 20 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
Sebia Normal Control Serum is indicated for the quality control of densitometric quantification of electrophoretic separations of human serum proteins, lipoproteins and lipoprotein-cholesterol fractions on Sebia HYDRAGELTM agarose gels. The Normal Control Serum is also indicated for the quality control of quantification of electrophoretic separations of human serum proteins on Sebia CAPILLARYS TM, the capillary electrophoresis system. The constituents of…
Read the full statement (186 words)
Sebia Normal Control Serum is indicated for the quality control of densitometric
quantification of electrophoretic separations of human serum proteins, lipoproteins and
lipoprotein-cholesterol fractions on Sebia HYDRAGELTM agarose gels. The Normal
Control Serum is also indicated for the quality control of quantification of electrophoretic
separations of human serum proteins on Sebia CAPILLARYS TM, the capillary
electrophoresis system.
The constituents of the Normal Control Serum are within the concentration ranges
(g/dL) expected in normal individuals. The relative (%) distribution of individual fractions
and the densitometric profile also reflect normal distribution.
Sebia Hypergamma Control Serum is indicated for the quality control of densitometric
quantification of electrophoretic separations of human serum proteins on HYDRAGEL
agarose gels and for the quality control of quantification of electrophoretic separations of
human serum proteins on CAPILLARYS, the capillary electrophoresis system.
The concentration of gammaglobulins in this control is elevated above the normal level.
The control values for all applicable tests for which the control materials are intended
are determined for each lot of Control Serum. The control values are published in the
product package insert included with each package of the Control Serum.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040925: Normal and Hypergamma Control Serum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040925
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026