(30 days)
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No
The 510(k) summary describes an in vitro diagnostic test for measuring autoantibodies, which is a standard laboratory assay and does not mention any AI or ML components.
No
Explanation: The device is described as an "in vitro diagnostic test" intended for measurement and screening of autoantibodies to aid in diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "set of in vitro diagnostic tests" and that its measurement "aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders".
No
The intended use describes an in vitro diagnostic test that measures autoantibodies in human serum. This inherently involves physical reagents and laboratory procedures, indicating it is not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The TheraTest EL-β2GPITM (IgM-IgG-IgA) is a set of in vitro diagnostic tests..."
- "The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test..."
This language clearly identifies the device as intended for use in vitro (outside of a living organism) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The TheraTest EL-β2GPITM (IgM-IgG-IgA) is a set of in vitro diagnostic tests for the measurement of IgM, IgG and IgA autoantibodies in human serum directed against serum beta 2-glycoprotein I (β2GPI). This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.
The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test for the screening for autoantibodies in human serum directed against the serum glycoprotein beta 2-glycoprotein I (B2GPI). This measurcment aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.
Product codes
MSV
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
Prescription use
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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§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT - 9 2009
Thera-Test Laboratories Inc. c/o Dr. Marius Teodorescu President and CEO 1111 N. Main St Lombard, IL 60148
Re: K092757
Trade/Device Name: TheraTest EL-β2GPI™ (IgM-IgG-IgA) & TheraTest EL-β2GPI™ Scr. Regulation Number: 21 CFR $866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: MSV Dated: September 8, 2009 Received: September 9, 2009
Dear Dr. Teodorescu:
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 class II (Special Controls), 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.
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Page 2 – Dr. Marius Teodorescu
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ie m chan
Maria M. Chan, Ph.D. 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 3 – Dr. Marius Teodorescu
Indications for Use
| 510(k)Number | K092757 |
|---|---|
| Device Name: | TheraTest EL-β2GPITM (IgM-IgG-IgA) |
Indications for Use. The TheraTest EL-β2GPITM (IgM-IgG-IgA) is a set of in vitro diagnostic
tests for the measurement of IgM, IgG and IgA autoantibodies in human serum directed against
serum beta 2-glycoprotein I (β2GPI). This measurement aids in the diagnosis of
antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as
those secondary to systemic lupus erythematosus.
Prescription use X
AND/OR ----------- Over-the-counter use -----
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)
3
Page 4 - Dr. Marius Teodorescu
Indications for Use
K092757 510(k)Number
Device Name: TheraTest EL-B2GPITM Scr
Indications for Use. The TheraTest EL-32GPI TM Scr is an in vitro diagnostic test for the screening for autoantibodies in human serum directed against the serum glycoprotein beta 2glycoprotein I (B2GPI). This measurcment aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.
Prescription use X
AND/OR
Over-the-counter use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)
. 1974
Reena Philip
Office of In Vitro Diagnosilo ഗ്വന്തര മേശ്വരിക്കു മുറിച്ച് ടിമ്പിക്