(48 days)
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No
The summary describes a laboratory test for detecting autoantibodies and does not mention any AI/ML components or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is a test kit for detecting autoantibodies, which aids in diagnosis and assessment of risk rather than providing direct therapy.
Yes
The text explicitly states that the kit is "intended to assess total anti-Cardiolipin autoantibody levels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk". It also mentions that the levels "represent one parameter in a multi-criterion diagnostic process," indicating its role in diagnosis.
No
The provided text describes a test kit for detecting autoantibodies in serum or plasma, which is a laboratory diagnostic device involving biological samples and reagents, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test is for the detection of autoantibodies in human serum or plasma. This indicates that the test is performed on samples taken from the human body, but outside of the body (in vitro).
- Purpose: The purpose is to aid in diagnosis and assessment of thrombotic risk, which is a typical application for IVD devices.
The definition of an IVD generally involves tests performed on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The test is for the semi-quantitative combined detection of IgG, IgM and IgA autoantibodies specific for the Phospholipid Cardiolipin in huma serum or plasma (EDTA, citrate, heparin)
The kit is intended to assess total anti-Cardiolipin autoantibody levels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk in patients with systemic lupus erythematosus or other lupus like disorders.
Total anti-Cardiolipin levels represent one parameter in a multi-criterion diagnostic process.
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): 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 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 2002 MAR
Ms. Eileen McCafferty Regulatory Affairs Manager Axis-Shield Diagnostics Limited Luna Place The Technology Park Dundee DD2 1XA Scotland
Re: K020156
Trade/Device Name: Axis-Shield DIASTAT™ Total Anti-Cardiolipin Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MID Dated: January 15, 2002 Received: January 17, 2002
Dear Ms. McCafferty:
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 for associated in the 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 11 your device to such additional controls. Existing major regulations affecting your device can may or subject to outsil are and 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 r rease of actived a determination that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I 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
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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and hype a ding 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 Sutman
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
MAR 6 2002
510(k) number if known. K. ما كامي 2015 6
Axis-Shield Total anti-Cardiolipin Elisa Device Name ...
Indications for Use The test is for the semi-quantitative combined detection of IgG, IgM and IgA autoantibodies specific for the Phospholipid Cardiolipin in huma serum or plasma (EDTA, citrate, heparin)
The kit is intended to assess total anti-Cardiolipin autoantibody levels in patients where this information is useful in diagnosis, particularly as an aid in the assessment of thrombotic risk in patients with systemic lupus erythematosus or other lupus like disorders.
Total anti-Cardiolipin levels represent one parameter in a multi-criterion diagnostic process.
Sonsun S. Altaie
Division Sian-Off Division of Clinical Laboratory Devices
K020156 510(k) Number-
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use ... ... ... ... ... ...... Per 21 CFR 801. 109
Over - the - Counter Use ... ... ......................