(62 days)
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No
The 510(k) summary describes qualitative calibrators/controls for an autoantibody test system and does not mention any AI or ML components.
No
The device is described as a qualitative calibrator/control to confirm the presence of antibodies, which indicates a diagnostic rather than therapeutic purpose.
No
The device is described as "qualitative calibrators/controls" to confirm the presence of antibodies, not as a device that performs the diagnostic test itself. It is intended for use with a separate "Autoantibody Test System."
No
The device description clearly states it is a "Positive Control Serum," which is a biological reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that these are "qualitative calibrators/controls to confirm the presence of antibodies to autoantigens (Jo-1, Scl-70, or PCNA) in human serum." This describes a test performed in vitro (outside the body) on a human specimen (serum) to provide information about a medical condition (presence of autoantibodies associated with specific diseases).
- Device Description: The device is described as "Positive Control Serum," which is a common component used in in vitro diagnostic tests to ensure the test is working correctly.
- Use with an IVD Test System: The intended use also states that these controls are "intended for use with the Immuno Concepts AUTO-ID® Autoantibody Test System." This further confirms their role as components within an in vitro diagnostic testing process.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. These controls fit this definition by being used to confirm the presence of markers associated with specific diseases.
N/A
Intended Use / Indications for Use
These are qualitative calibrators/controls to confirm the presence of antibodies to autoantigens (Jo-1, Scl-70, or PCNA) in human serum. Antibodies to Jo-1 are found in patients with polymyositis and dermatomyositis, antibodies to Scl-70 are found in patients with scleroderma, and antibodies to PCNA are found in patients with systemic lupus erythematosus. These optional controls are intended for use with the Immuno Concepts AUTO-ID® Autoantibody Test System.
Product codes
LKJ
Device Description
AUTO-I.D.® Jo-1 Positive Control Serum (Catalog number 6004)
AUTO-I.D.® Sc1-70 Positive Control Serum (Catalog number 6005)
AUTO-I.D.® PCNA Positive Control Serum (Catalog number 6006)
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Eric S. Hoy, Ph.D., AI(ASCP) Chief Scientific Officer Immuno Concepts Incorporated 9779 "D" Business Park Drive Sacramento, California 95827
K030775 Trade/Device Name: Auto I.D.® Jo-1 Positive Control Auto I.D.® Scl-70 Positive Control Auto I.D.® PCNA Positive Control Regulation Number: 21 CFR & 866.5100 Regulation Name: ANA Immunological Test System Regulatory Class: II Product Code: LKJ Dated: March 10, 2003 Received: March 11, 2003
Dear Dr. Hoy :
Re:
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.
MAY 1 2 2003
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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(k) number (if known):
Device Name: AUTO I.D.® Positive Control Serum
HD30 175
Trade or Proprietary Name:
AUTO-I.D.® Jo-1 Positive Control Serum (Catalog number 6004) AUTO-I.D.® Sc1-70 Positive Control Serum (Catalog number 6005) AUTO-I.D.® PCNA Positive Control Serum (Catalog number 6006)
Indications for use:
These are qualitative calibrators/controls to confirm the presence of antibodies to autoantigens (Jo-1, Scl-70, or PCNA) in human serum. Antibodies to Jo-1 are found in patients with polymyositis and dermatomyositis, antibodies to Scl-70 are found in patients with scleroderma, and antibodies to PCNA are found in patients with systemic lupus erythematosus. These optional controls are intended for use with the Immuno Concepts AUTO-ID® Autoantibody Test System.
(PLEASE'DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H. Reeves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number (20307, 5
Prescription Use
(Per 21 CFR 801.109) √
OR Over-The-Counter Use