(123 days)
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No
The summary describes a standard ELISA kit, which is a laboratory assay and does not involve AI or ML technology. There are no mentions of AI, ML, image processing, or any other indicators of such technology.
No
This device is an in vitro diagnostic (IVD) test for detecting antibodies to aid in the diagnosis of certain autoimmune liver diseases, not a therapeutic device designed to treat or alleviate disease.
Yes
The device is used for the semi-quantitative detection of IgG antibodies, which is "an aid in diagnosis of certain autoimmune liver diseases".
No
The device is an ELISA kit, which is a laboratory assay involving physical reagents and procedures, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kit is for the "semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis.
- Aid in Diagnosis: The intended use also states that the detection of these antibodies is an "aid in diagnosis of certain autoimmune liver diseases." This directly aligns with the purpose of IVDs, which are used to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
- Device Description: The description confirms it's an "enzyme-linked immunosorbent assay (ELISA)," which is a common type of in vitro diagnostic test.
The key characteristics of an IVD are that it is used to examine specimens derived from the human body to provide information for clinical purposes. This device fits that definition perfectly.
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Intended Use / Indications for Use
The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).
Product codes
NJF
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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5120 Antismooth muscle antibody immunological test system.
(a)
Identification. An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).(b)
Classification Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing another, symbolizing care and protection. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.
Public Health Service
SEP 2 0 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
K021648 Re: Trade/Device Name: QUANTA Lite™ Actin ELISA Regulation Number: 21 CFR § 866.5120 Regulation Name: Anti-smooth Muscle Antibody Immunological Test System Regulatory Class: II Product Code: NJF Dated: July 29, 2002 Received: July 29, 2002
Dear Mr. Myers:
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. Iisting 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 mav 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K021648
Device Name: QUANTA Lite™ Actin ELISA
Indications For Use:
The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deborah M. Moore
(Division Sign-Off)
ation of Clinical Laboratory Division of Clinical
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Image /page/2/Picture/10 description: The image shows the words "Prescription Use" in bold font, followed by a check mark. Below that, the text "(Per 21 CFR 801.109)" is printed. The check mark indicates that the product is for prescription use only. The CFR reference provides the regulatory context for this designation.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)