(57 days)
The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG antibodies 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.
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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called the "QAB2A IgG Elisa Kit HRP." This document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device, rather than a detailed study evaluating its performance against specific acceptance criteria.
Therefore, the specific information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from the provided text. The document does not describe a performance study as you've outlined.
However, I can infer some aspects and highlight what is missing:
Information that can be partially inferred or is explicitly mentioned:
- Device Name: QAB2A IgG Elisa Kit HRP
- Intended Use: "Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG antibodies 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."
Information that is NOT present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not contain a table or description of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or the actual performance results of the QAB2A IgG Elisa Kit HRP.
- Sample size used for the test set and the data provenance: There is no mention of a test set sample size or its origin (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The text does not describe any human experts being used to establish ground truth for a test set.
- Adjudication method for the test set: No adjudication method is mentioned as a test set isn't detailed.
- 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: This device is an immunoassay kit, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study with human readers and AI assistance is not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is an immunoassay kit, the concept of "algorithm only" performance (as in AI) doesn't directly apply. Its performance is measured by its analytical and clinical validity directly.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The document does not specify how ground truth would be established for any performance claims, though for an ELISA kit, it would typically involve clinical diagnosis, other standard tests, or possibly pathology/outcome data for cases of thrombosis.
- The sample size for the training set: Not applicable and not mentioned, as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable and not mentioned.
Summary:
The provided FDA 510(k) clearance letter confirms that the QAB2A IgG Elisa Kit HRP is "substantially equivalent" to predicate devices, allowing it to be marketed. However, it does not include the detailed performance study data, acceptance criteria, or methodological specifics that you've requested. Such information would typically be detailed in the 510(k) submission itself, not necessarily in the FDA clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
JUL 12 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Neil Stringer Managing Director Cheshire Diagnostics Limited 7 Elm Street Ellesmere Port Cheshire CH65 3EN
Re: K021611
Trade/Device Name: QAB2A IgG Elisa Kit HRP Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MSV Dated: June 24, 2002 Received: June 28, 2002
Dear Mr. Stringer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 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.
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.
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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. . Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
QAß2A IgG Elisa Kit HRP Device Name:
Indications for Use: The Cheshire Diagnostics Limited QAß2A IgG Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG antibodies 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)
A.P. Reeves for S. Athair
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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).