NORMAL AND HYPERGAMMA CONTROL SERUM

K040925 · Sebia · JJY · Apr 28, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040925
• Device Name: NORMAL AND HYPERGAMMA CONTROL SERUM
• Applicant: Sebia
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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 HYDRAGEL™, 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™, 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 Sebia CAPILLARYS™, the capillary electrophoresis system. The concentration of gammaglobulins in this control is elevated above the normal level.

Device Story

Sebia Normal and Hypergamma Control Serums are lyophilized human serum-based quality control materials. Used in clinical laboratories to verify performance of electrophoretic separation systems (HYDRAGEL agarose gels and CAPILLARYS capillary electrophoresis). Normal Control Serum contains physiological concentrations of serum proteins; Hypergamma Control Serum contains elevated gamma globulin levels. Healthcare providers use these controls to validate densitometric quantification of electrophoretic fractions. By comparing measured control values against provided assayed ranges (mean ± 2 S.D.), clinicians ensure accuracy and reproducibility of patient sample testing, supporting reliable diagnostic decision-making for protein-related disorders.

Clinical Evidence

No clinical data. Bench testing only; values derived from repetitive measurements to establish mean and 2 S.D. ranges for electrophoretic fractions.

Technological Characteristics

Lyophilized human serum-based control material. Analyte quantification via densitometry (HYDRAGEL) or direct absorbance at 200 nm (CAPILLARYS). Storage at -20°C or colder.

Indications for Use

Indicated for quality control of electrophoretic separation and quantification of human serum proteins, lipoproteins, and lipoprotein-cholesterol fractions. Used with Sebia HYDRAGEL agarose gels and CAPILLARYS capillary electrophoresis systems. Normal Control Serum contains constituents within normal concentration ranges; Hypergamma Control Serum contains elevated gammaglobulin levels.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K040925

B. Purpose for Submission:
New device

C. Analyte:
Albumin, alpha-1 globulins, alpha-2 globulins, beta-1 globulins, beta-2 globulins, gamma globulins

D. Type of Test:
Quality Control Material

E. Applicant:
Sebia Inc.

F. Proprietary and Established Names:
Sebia Normal Control Serum
Sebia Hypergamma Control Serum

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660
2. Classification:
Class I
3. Product Code:
JJY
4. Panel:
75

H. Intended Use:
1. Intended use(s):
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 HYDRAGEL™, 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™, 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 Sebia CAPILLARYS™, the capillary electrophoresis system. The

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concentration of gammaglobulins in this control is elevated above the normal level.

2. Indication(s) for use:
Same as above

3. Special condition for use statement(s):
Not applicable

4. Special instrument Requirements:
Values are listed for each analyte.

I. Device Description:
The Sebia Normal Control Serum and the Sebia Hypergamma Control Serum are presented in a lyophilized form. There are five vials of control serum per package (box). Each box is supplied with Package Insert/Instruction sheet that contains instruction for use, information on storage conditions and shelf life. Each package insert provide ranges of assayed densitometric control values (relative percent mean ± 2 S.D.) for individual analytes (electrophoretic fractions).

J. Substantial Equivalence Information:
1. Predicate device name(s):
BioRad Liquicheck Controls
2. Predicate K number(s):
K903430
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Normal and Hypergamma Control Serums | BioRad Liquicheck Controls |
| Intended Use | Control sera for electrophoretic based tests and quantification of the resulting migration patterns by densitometry | Control sera for electrophoretic based tests and quantification of the resulting migration patterns by densitometry |
| Matrix | Human serum based | Human serum based |
| Storage | - 20° C or colder | - 20° C or colder |
| Differences | | |
| Item | Device | Predicate |
| Form | Lyophilized | Frozen |

K. Standard/Guidance Document Referenced (if applicable):
None referenced

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:

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Not applicable

b. Linearity/assay reportable range:
Not applicable

c. Traceability (controls, calibrators, or method):
The mean values were derived from repetitive measurements ± 2 SD. The electrophoretic separations on HYDRAGEL gels of the various human serum components constituting the control sera are first visualized by appropriate means that are specific for each type of test. The visualized electrophoretic separations are then subjected to densitometry. The densitometric values for the individual electrophoretic fractions of interest form the basis for calculating the control values. The serum protein fractions separated on CAPILLARYS are measured directly by their absorbance at 200 nm.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a and b are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Conclusion:
The submitted material in this premarket notification is complete and supports a substantial equivalence decision.