# K040925: Normal and Hypergamma Control Serum

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Apr 28, 2004 after 20 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K040925
Methodology: https://510kreport.com/methodology