NORMAL AND HYPERGAMMA CONTROL SERUM by SEBIA

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 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.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for a control serum device, specifically "Normal Control Serum" and "Hypergamma Control Serum." It is not a diagnostic device, and therefore the concepts of acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), ground truth, training/test sets, or expert reviews for clinical diagnosis are not applicable in the same way they would be for an AI-powered diagnostic tool.

This document describes the regulatory approval of quality control materials used to verify the performance of other diagnostic tests (electrophoretic separations). The "performance" of these control serums relates to their stability, consistency, and how well they reflect known values when run on specified platforms.

Therefore, I cannot extract the information requested in your prompt because the input document does not contain a study demonstrating the "device's performance" in a clinical diagnostic sense. Instead, it describes a control material and its intended use for quality control.

Here's why each point in your request cannot be fulfilled based on the provided text:

A table of acceptance criteria and the reported device performance: This document does not present specific performance metrics like sensitivity or specificity for the control serum. The "performance" here refers to its suitability as a quality control material. The acceptance criteria for these types of devices typically relate to their formulation, stability, and the range of expected values when used with target assays.
Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the sense of patient data for evaluating a diagnostic algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a control serum is its known chemical composition and the expected values it should yield on a properly functioning instrument. No clinical experts are involved in establishing this for a control material.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a control material is its chemically defined composition and the established reference values for its constituents, often determined by highly accurate reference methods or certified standards.
The sample size for the training set: Not applicable. There is no training set as it's not an AI model.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

Device Name: Normal Control Serum, Hypergamma Control Serum
Indications For Use: Quality control for densitometric quantification of electrophoretic separations of human serum proteins, lipoproteins, and lipoprotein-cholesterol fractions on specific Sebia systems (HYDRAGEL™ agarose gels and CAPILLARYS™ capillary electrophoresis system).
Key "performance" aspect mentioned: "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." This describes the manufacturer's responsibility to characterize each lot of control material.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 8 2004

Borek Janik, Ph.D. Official Correspondent Sebia 13805 Waterloo Chelsea, MI 48118

Re: K040925

Trade/Device Name: Normal Control Serum Hypergamma Control Serum Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: April 5, 2004 Received: April 15, 2004

Dear Dr. Janik:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Joseph L. Aralett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K040925

Device name:

1. NORMAL CONTROL SERUM	PN 4785
2. HYPERGAMMA CONTROL SERUM	PN 4787

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Thana Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety Over-The Counter Use KO40925 510(k) __

Prescription Use X (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.