(14 days)
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT).
The assay is a tool in the diagnosis of certain systemic theumatic diseases and should be used in conjunction with other serological tests and clinical findings.
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens.
I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request regarding the acceptance criteria and the study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "AESKULISA ANA-HEp2," and while it states the device has been found substantially equivalent to a predicate device, it does not include the specific study details you are asking for.
Here's a breakdown of what I can and cannot provide based on the given text:
Information I CAN extract:
- Device Name: AESKULISA ANA-Hep2
- Indication for Use: A solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. It collectively detects total ANAs against dsDNA, histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1, and centromeric antigens, along with sera positive for HEp2 immunofluorescence test (IFT). It's a tool in the diagnosis of certain systemic rheumatic diseases and should be used with other serological tests and clinical findings.
- Regulatory Information: Class II device, Product Code LKJ.
Information NOT present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not detail specific acceptance criteria or the performance metrics (e.g., sensitivity, specificity, accuracy) from the study.
- Sample sizes used for the test set and data provenance: The document does not mention the sample size of any test set or the origin of the data.
- Number of experts used to establish the ground truth for the test set and their qualifications: There is no mention of experts or ground truth establishment.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable as this is not an AI-assisted device based on the description.
- Standalone (algorithm only) performance: Not applicable as this is an immunoassay, not an algorithm.
- Type of ground truth used: Not specified.
- Sample size for the training set: There is no mention of a training set as this is an immunoassay, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Therefore, I cannot fulfill your request for the specific study details as they are not contained within the provided FDA 510(k) clearance letter. This type of information would typically be found in the 510(k) submission summary or the actual study report, neither of which is present here.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 2 2008
Aesku Diagnostics. c/o Intertek Testing Services Attn: Mr. Jay Y Kogoma 2307 East Aurora Rd Twinsburg, OH 44087
Re: K081104
Trade/Device Name: AESKULISA ANA-Hep2 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LKJ Dated: April 14, 2008 Received: April 18, 2008
Dear Mr. Kogoma:
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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker Jr
Robert L. Becker, Jr., M.D., Ph.I Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Special 510(k): Device Modification
6.4 Indication for Use
510(K) Number (if Known): KOS 110 4
Device Name: AESKULISA ANA-HEp2
Indication For Use:
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG artibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells and spectic antigens. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT).
The assay is a tool in the diagnosis of certain systemic theumatic diseases and should be used in conjunction with other serological tests and clinical findings.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
m chan
Office of In Vitro Diagnostic Device Evaluation and Sa
510(k) K081104
6-53
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).