(380 days)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative : detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Not Found
The document provided is a 510(k) clearance letter from the FDA for several ImmuLisa Enhanced™ Cardiolipin Antibody (ACA) ELISA tests, indicating they are substantially equivalent to legally marketed predicate devices. It does not contain details about acceptance criteria or specific study results related to the performance of these devices.
The typical content of a 510(k) clearance is an affirmation of substantial equivalence, not a detailed report of clinical study outcomes or device performance against pre-defined acceptance criteria. Therefore, most of the information requested in your prompt cannot be extracted from this document.
Here's what can be inferred or stated based on the document:
- Acceptance Criteria and Reported Device Performance: Not provided in the document. The FDA determined substantial equivalence, but the specific performance of the device or the criteria it met are not detailed here.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided, as this document is a regulatory clearance, not a study report.
- Adjudication method for the test set: Not applicable or provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable or provided, as these are in vitro diagnostic (IVD) tests, not typically subject to MRMC studies in the same way as imaging algorithms.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. These are lab-based ELISA tests, not AI algorithms.
- The type of ground truth used: Not specified, as the document doesn't detail the studies. For IVDs, ground truth is typically established by reference methods, clinical diagnosis, or patient outcomes.
- The sample size for the training set: Not applicable or provided, as these are lab-based ELISA tests, not AI algorithms requiring a training set in the machine learning sense.
- How the ground truth for the training set was established: Not applicable or provided.
In summary, this document is a regulatory approval notice and does not contain the detailed scientific study information requested. To find such information, one would typically need to review the 510(k) submission itself (which is often extensive and not publicly available in its entirety) or peer-reviewed publications related to the device.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
OCT 25 2012
IMMCO Diagnostics, Inc. c/o Mr. Kevin J. Lawson VP Regulatory Affairs 60 Pineview Drive, Buffalo, NY 14228
Re: K113020
Trade/Device Name: ImmuLisa Enhanced™ Cardiolipin IgA Antibody (ACA) ELISA ImmuLisa Enhanced™ Cardiolipin IgG Antibody (ACA) ELISA ImmuLisa Enhanced™ Cardiolipin IgM Antibody (ACA) ELISA ImmuLisa Enhanced™ Cardiolipin IgA/IgG/IgM Antibody (ACA) ELISA
Regulation Number: 21 CFR §866.5660
Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID Dated: October 23, 2012 Received: October 24, 2012
Dear Mr. Lawson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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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Page 2 - Mr. Kevin Lawson
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 or any is all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
ia m chan
Maria M. Chan, Ph.D. Director Division Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K113020
ImmuLisa Enhanced™ Cardiolipin IgA Antibody (ACA) Device Name: ELISA
Enzyme linked immunoassay (ELISA) for the qualitative or Indications For Use: semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
NZP Nizan Panyon
Division Sign-Off
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safaty
510K K113020
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510(k) Number (if known): K113020
Device Name:
ImmuLisa Enhanced ™ Cardiolipin IgG Antibody (ACA) ELISA
Indications For Use:
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
NZF Ntar Samper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113020
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510(k) Number (if known): K113020
ImmuLisa Enhanced™ Cardiolipin IgM Antibody (ACA) ELISA
Indications For Use:
Device Name:
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
NZP Nisar Rampen
Initials Sign-Off
Division Sign-C
Office of In Vitro Diagnostic Omce of Interest and Safet
518K K11302 J
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510(k) Number (if known): K113020
Device Name:
ImmuLisa Enhanced ™ Cardiolipin IgA/IgG/IgM Antibody (ACA) ELISA
Indications For Use: Enzyme linked immunoassay (ELISA) for the qualitative : detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
NZP Nisar Ramyr
Division Sig
Office of In Vitro Diagnost Office Evaluation and
Device
510K K113020
§ 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).