(72 days)
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative Adelection of IgG antibodies against HEp-2 cells in human serum. Each well is coated with lysed HEp2 cells and specific 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 rheumatic 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 Adelection of IgG antibodies against HEp-2 cells in human serum. Each well is coated with lysed HEp2 cells and specific antigens.
This document is a 510(k) clearance letter from the FDA for a medical device called AESKULISA ANA Hep-2. It does not contain the detailed study information required to fill out the table and answer the questions about acceptance criteria and device performance.
The provided text only includes:
- The device name: AESKULISA ANA Hep-2
- The regulation number and name: 21 CFR 866.5100, Antinuclear antibody immunological test systems
- The product code: LKJ
- The indications for use: combined qualitative detection of IgG antibodies against HEp-2 cells in human serum, collectively detecting total ANAs against various antigens, and serving as a tool in the diagnosis of certain systemic rheumatic diseases to be used with other tests and clinical findings.
To answer your questions, I would need a detailed study report, clinical trial results, or data from the 510(k) submission itself which would provide specific performance metrics, study designs, and ground truth methodologies. This information is not present in the provided FDA clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
JUN 2 3 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Stanley Ammons US Correspondent AESKU Inc. 8880 Northwest 18th Terrace Miami, FL 33172
K040953 Re: Trade/Device Name: AESKULISA ANA Hep-2 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test systems Regulatory Class: Class II Product Code: LKJ Dated: June 8, 2004 Received: June 16, 2004
Dear Mr. Ammons:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to region) to regions of the Medical Device Amendments, or to connine.co. pror to May 20, 1970, the oncordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic (11ct) that as novice, subject to the general controls provisions of the Act. The r ou may, mercrore, maines of the Act include requirements for annual registration, listing of general controls provisions of tactice, 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 your device is enabilitional controls. Existing major regulations affecting your device It may be subject to such additions combiner - Mations (CFR), Parts 800 to 895. In addition, FDA can be found in Title 21, Occerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean F lease be advised that I Dris issualles or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally it dollars and regulations and regulations, but not limited to: registration and listing (21 Comply with an the Ace of Equilters, 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your evice to a legally premarket notification. "The PDA midning of basisan 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, If you desne specific information assuments of your device, please contact the Office of In or questions of the promotion and acreensing or your be and services of the Vitro Diagnostic Device Device Livanian and bareer an (Secondon' (21CFR Part 807.97). fegulation entitled, "Misolanding of responsibilities under the Act from the You may offain offer general miormation on Jour 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,
Roba H. Beckwith
Robert L. Becker, Jr. MD, PH. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Addendum C for K040953
510(k) Number (if known):K040953____________________________________________________________________________________________________________________________________________
Device Name: AESKULISA ANA HEp-2_
Indications For Use:
AESKULISA ANA-HEp2 is a solid phase enzyme immunoassay for the combined qualitative Adelection of IgG antibodies against HEp-2 cells in human serum. Each well is coated with lysed HEp2 cells and specific 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 rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Maria Chan
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K040953
§ 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).