(127 days)
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No
The 510(k) summary describes a standard ELISA assay for detecting antibodies, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is an in vitro diagnostic (IVD) test that detects antibodies to aid in diagnosis, rather than directly treating a condition.
Yes
The device is described as an aid in the diagnosis of specific medical conditions, which is the definition of a diagnostic device.
No
The 510(k) summary describes an ELISA kit, which is a laboratory assay involving physical reagents and processes, 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 device is an "enzymelinked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera." This involves testing biological samples (patient sera) outside of the body.
- Purpose: The purpose is to aid in the diagnosis of various autoimmune diseases (systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis) by detecting specific antibodies in the serum. This is a diagnostic purpose.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzymelinked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Product codes
OBE
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a circular seal or logo. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter of the circle. In the center of the seal is a stylized symbol that resembles three overlapping, curved lines or strokes, creating a sense of movement or flow. The overall design is simple and professional, suggesting an official or governmental affiliation.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 4 - 2007
INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers Manager, Regulatory Affairs 9900 Old Grove Rd San Diego, CA 92131-1638
Re: K063565
Trade/Device Name: QUANTA Lite™ SS-A 52 ELISA Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: OBE Dated: February 15, 2007 Received: February 20, 2007
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, 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), 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,
chan for
Dr. Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. 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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Page 7 of 30
510(k) Number (if known): _ H 063565
Device Name: QUANTA Lite™ SS-A 52 ELISA
Indications For Use:
The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzymelinked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR (Per 21 CFR 801.109) ma
ﻘﺪ ﺗﺮﻳﺔ ﺍﻟﻤﺮﻳﻢ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﻓﻲ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﻓﻲ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
Over-The-Counter Use_
(Optional Format 1-2-96)
Cribe of in Vitro Diagnostic Device Evaluation and Safery
510(K) KO63565