(46 days)
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No
The summary describes a standard ELISA kit for detecting antibodies, with no mention of AI or ML in the intended use, device description, or other sections.
No
The device is an Elisa Kit for detection of autoantibodies to aid in risk assessment, not for treatment.
Yes
The device is used to detect an autoantibody in human serum which can aid in the assessment of the risk of thrombosis in patients with certain conditions. This is a diagnostic function.
No
The device description and intended use clearly describe an "Elisa Kit," which is a laboratory test kit containing reagents and other physical components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kit is for the detection of an autoantibody in human serum. This means it's used to test a sample taken from the human body.
- Method: It uses an enzyme-linked immunoassay (ELISA), which is a common laboratory technique performed in vitro (outside the living organism) to detect and quantify substances in biological samples.
- Purpose: The results are used to aid in the assessment of the risk from thrombosis in patients with specific conditions. This indicates a diagnostic purpose, providing information to help in the diagnosis or management of a disease or condition.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the in vitro examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description.
N/A
Intended Use / Indications for Use
The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgG isotype autoantibody to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.
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
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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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§ 866.5660 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).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 1 2005
Mr. Neil B. Stringer Managing Director Cheshire Diagnostics Ltd. Management Centre, Inward Way Ellesmere Port Cheshire United Kingdom CH 65 3EN
Re: K020695
Trade/Device Name: QAB2A IgG Elisa Kit AP Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: March 1,2002 Received: March 4, 2002
Dear Mr. Stringer:
This letter corrects our substantially equivalent letter of April 19, 2002 regarding the OAB2A IgG Elisa Kit AP in which the wrong product code was used.
We have reviewed your Section 510(k) premarket notitication 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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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); 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.
This letter will allow you to continue 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0131. Also, please note the regulationentitled, "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.qov/cdrh/dsrna/dsrnarnain.htrnl
Sincerely yours,
Robert Becker Jr.
Robert L. Becker, Jr., M.D., Ph& 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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QAß2A IgG Elisa Kit 510(k)
Indications for Use Statement
KO20695 510(k) Number:____
QAß2A IgG Elisa Kit AP Device Name:
Indications for Use: The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit is a semi quantitative enzyme linked immunoassay for the detection of the IgG isotype autoantibody to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the
assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other Lupus like disorders.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sausan S. Alta.e
510(k) Number*K020645*
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-the-counter Use
(Optional Format 1-2-96)
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