(134 days)
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No
The description details a standard enzyme immunoassay (ELISA) for detecting antibodies, which is a biochemical method and does not inherently involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No.
This device is an immunoassay intended for diagnostic purposes (detection of antibodies) and does not provide therapy.
Yes
The text explicitly states that the device "can be used as an aid in the diagnosis of thrombotic disorders."
No
The device description is not provided, but the intended use clearly describes a "solid phase enzyme immunoassay" which is a laboratory test involving physical reagents and processes, not solely software.
Yes, based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are used for the "detection of IgA, IgG and/or IgM antibodies against ß2 glycoprotein I in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
- Purpose: The purpose is to "be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome." This is a diagnostic purpose, which is a key characteristic of IVDs.
- Method: The method described is a "solid phase enzyme immunoassay," which is a common laboratory technique used for in vitro testing.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided text aligns perfectly with this definition.
N/A
Intended Use / Indications for Use
AESKULISA ß2 Glyco-A is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
AESKULISA ß2 Glyco-GM is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the separate semiquantitative and qualitative detection of IgG and/oArmIgM antibodies against ß2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
AESKULISA ß2 Glyco-Check is a solid phase enzyme immunoassay employing native ß2 glycoprotein 1 highly purified from human plasma for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against ß2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
Product codes (comma separated list FDA assigned to the subject device)
MSV
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
Prescription Use
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 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted with flowing lines, giving it a dynamic and modern appearance.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AESKU, Inc. c/o Mr. David Bell US Correspondent 8880 Northwest 18th Terrace Miami, FL 33172
DEC I 3 2006
Re: K062217
Trade/Device Name: AESKULISA® ß2-Glyco-A Protocol 30-30-30, AESKULISA® B2-Glyco-A Protocol 30-15-15, AESKULISA® ß2-Glyco-GM Protocol 30-30-30, AESKULISA® β2-Glyco-GM Protocol 30-15-15, AESKULISA® β2-Glyco-Check Protocol 30-30-30, AESKULISA® β2-Glyco-Check Protocol 30-15-15 Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: MSV Dated: July 31, 2006 Received: August 3, 2006
Dear Mr. Bell:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin 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) 276-0484. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert A. Bertoch
Robert L. Becker, Jr., M.D., Pb.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
2
3 Indications for use
510(k) Number (if known):_ 4062217
Device Name: AESKULISA ß2-Glyco-A
Indications For Use:
AESKULISA ß2 Glyco-A is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum.
The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
m chan
Division Sign-Off
510(k) K062217
(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)
3
510(k) Number (if known): ¥0622 17
Device Name: AESKULISA β2-Glyco-GM
Indications For Use:
AESKULISA ß2 Glyco-GM is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the separate semiquantitative and qualitative detection of IgG and/or IgM antibodies against β2 glycoprotein I in human serum.
The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
Maria M. Clan
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K062217
(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
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
3-2
4
510(k) Number (if known): .
Device Name: AESKULISA B2-Glvco-Check
Indications For Use:
AESKULISA ß2 Glyco-Check is a solid phase enzyme immunoassay employing native ß2 glycoprotein 1 highly purified from human plasma for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against ß2 glycoprotein I in human serum.
The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
Marie M. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062217
(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)