(31 days)
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No
The document describes a standard Enzyme Linked Immunoassay (ELISA) kit, which is a biochemical test. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies.
No.
The device is an in vitro diagnostic test used for the semiquantitative detection of antibodies, aiding in risk assessment, not for therapy or treatment.
Yes
The "Intended Use" section explicitly states that the device is "for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum," and that the "presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis." This description indicates that the device provides information used to aid in the diagnosis or assessment of a medical condition.
No
The device description clearly states it is an "Enzyme Linked Immunoassay," which is a laboratory test involving physical reagents and procedures, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The "Device Description" also reiterates that it is an "Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum."
IVDs are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description by analyzing human serum to detect antibodies for diagnostic aid.
N/A
Intended Use / Indications for Use
The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.
The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.
Product codes
MID
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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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a person's head and body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 6 2002
Mr. Neil B. Stringer Managing Director Cheshire Diagnostics Limited The Management Centre Inward Way, Ellesmere Port Cheshire, CH65 3EN England
K021192 Re:
Trade/Device Name: QACA IgG/IgM Elisa Kit HRP Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MID Dated: April 11, 2002 Received: April 15, 2002
Dear Mr. Stringer:
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 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/cdrh/dsma/dsmamain.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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510(k) QACA IgG/IgM Elisa Kit HRP
Indications for Use Statement
510(k) Number: K 021/92
Device Name:
QACA IgG/IgM Elisa Kit HRP
Indications for Use: The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.
The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) 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)
Sousan S. Altaie
(Division Sign-Off) Division of Clinical Laborato 510(k) Number
Prescription Use v (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)