(247 days)
AESKULISA tTg A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig A antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA tTg G is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig G antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
AESKULISA tTg A is a solid phase enzyme immunoassay.
AESKULISA tTg G is a solid phase enzyme immunoassay.
This FDA Premarket Notification (510(k)) letter does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance as it focuses on the substantial equivalence determination for regulatory purposes.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for a specific study.
- Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
- Results of standalone algorithm performance.
The provided document is a regulatory approval letter stating that the AESKULISA tTg A and G assays are substantially equivalent to legally marketed predicate devices, and outlines their intended use as aids in the diagnosis of celiac disease. It does not delve into the specifics of the performance studies that would have been submitted as part of the 510(k) application.
To get the information you are looking for, you would typically need to refer to the actual 510(k) submission document itself (which is usually a much larger technical file) or scientific publications related to the device's validation. This approval letter is merely the FDA's formal response to that submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2005
AESKU, Inc. c/o Mr. Stanley Ammons 8880 Northwest 18th Terrace Miami, FL 33172
Re: K042644 Trade/Device Name: AESKULISAB tTG A Protocol 30-15-15 REF 7503 AESKULISAB tTG A Protocol 30-30-30 REF 7503 AESKULISA®tTG G Protocol 30-15-15 REF 7504 AESKULISAB tTG G Protocol 30-30-30 REF 7504 Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: September 15,2004 Received: September 27,2004
Dear Mr. Ammons:
This letter corrects our substantially equivalent letter of June 1,2005 regarding AESKULISAB tTG A Protocol 30-15-15 REF 7503, AESKULISAB tTG A Protocol 30-30-30 REF 7503. AESKULISAB tTG G Protocol 30-15-15 REF 7504 and AESKULISAB tTG G Protocol 30-30-30 REF 7504 in which the regulation number was incorrectly entered.
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 (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 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
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Page 2 - Mr. Stanley Ammons
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.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0131. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mana Chan signed for
Dr. Robert L. Becker
Robert L. Becker, Jr., M.D., PhD 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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510(k) Number (if known): K042644
Device Name: AESKULISA tTg A
Indications For Use:
AESKULISA tTg A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig A antibodies against tissue transglutaminase (tTG) in human serum.
The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) 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 X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) Over-The-Counter Use - - -
Mana M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042644
B-3
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Appendix B
510(k) Number (if known): K042644
Device Name:_AESKULISA tTg G
Indications For Use:
AESKULISA tTg G is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig G antibodies against tissue transglutaminase (tTG) in human serum.
The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) 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)
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
Over-The-Counter Use
Maree M. Clark
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042644
B-4
§ 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).