(57 days)
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No
The 510(k) summary describes an ELISA kit, which is a laboratory diagnostic test based on biochemical reactions, not AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
This device is an in vitro diagnostic (IVD) test used for semiquantitative detection of IgM antibodies, aiding in risk assessment. It does not provide therapy or treatment.
Yes
The intended use explicitly states "aid in the assessment of the risk from thrombosis," indicating its role in diagnosis for clinical decision-making.
No
The device is described as an "Elisa Kit," which is a laboratory assay kit containing reagents and physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "in vitro semiquantitative detection of IgM antibodies to ß2-Glycoprotein-I in human serum." This clearly indicates that the test is performed outside of the body ("in vitro") on a biological sample ("human serum") to detect a specific substance ("IgM antibodies to ß2-Glycoprotein-I").
- "Enzyme Linked Immunoassay" This describes a common laboratory technique used for in vitro diagnostic testing.
These phrases are key indicators that the device is intended for use in a laboratory setting to diagnose or aid in the diagnosis of a condition by analyzing a sample from the human body.
N/A
Intended Use / Indications for Use
The Cheshire Diagnostics Limited QAß2A IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgM 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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
'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: K021610
Trade/Device Name: QAB2A IgM 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 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/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
2
Indications for Use Statement
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name:
QAß2A IgM Elisa Kit HRP
Indications for Use: The Cheshire Diagnostics Limited QAß2A IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgM 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)
J. Reeves for S. Altaie
ical Laboratory Devices
K021660
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)