(20 days)
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No
The document describes control serums used for quality control of electrophoretic separations, which is a standard laboratory technique. There is no mention of AI or ML in the intended use, device description, or any other section. The "densitometric quantification" refers to measuring the density of bands on a gel, which is a standard analytical method, not necessarily involving AI/ML.
No
The device is described as a control serum used for quality control of electrophoretic separations, not for treating or diagnosing a disease or condition in a patient.
No
Explanation: The device is indicated for quality control of electrophoretic separations, not for diagnosing medical conditions in patients. It is used to ensure the accuracy of other diagnostic tests.
No
The device description is not found, but the intended use clearly describes control serums used for quality control of electrophoretic separations on physical systems (HYDRAGEL agarose gels and CAPILLARYS system). This indicates a physical control material, not a software-only device.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "quality control of densitometric quantification of electrophoretic separations of human serum proteins, lipoproteins and lipoprotein-cholesterol fractions" and "quality control of quantification of electrophoretic separations of human serum proteins". This indicates it's used to evaluate the performance of diagnostic tests performed on human biological samples (serum).
- Anatomical Site: The device is used with "human serum", which is a biological sample.
- Purpose: The purpose is quality control for diagnostic tests, which is a key function of IVD devices.
The description aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / 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 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.
Product codes
JJY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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:
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.
(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)