(49 days)
Not Found
Not Found
No
The summary describes a fluorescent immunosorbent assay for detecting autoantibodies, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for the semi-quantitative detection of autoantibodies to aid in the diagnosis of certain diseases. It is not designed to treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states that the device aids "in the diagnosis of systemic lupus erythematosus and related connective tissue diseases".
No
The device description is not found, but the intended use clearly describes a fluorescent immunosorbent assay, which is a laboratory test involving physical reagents and equipment, not solely software.
Yes, based on the provided information, the QUANTA Plex™ ENA Profile 6 is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70 and Jo-1 autoantibodies in human serum." This involves testing biological samples (human serum) in vitro (outside the body).
- Purpose: The purpose is to "aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases." This is a diagnostic purpose, which is a key characteristic of IVDs.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The QUANTA Plex™ ENA Profile 6 clearly fits this description.
N/A
Intended Use / Indications for Use
The QUANTA Plex™ ENA Profile 6 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70 and Jo-1 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren's syndrome, scleroderma and polymyositis.
Product codes
LLL
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2003
Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, CA 92131
Re: K031450
Trade/Device Name: QUANTA Plex™ ENA Profile 6 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL Dated: May 6, 2003 Received: May 12, 2003
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 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) 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 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 (301) 594-3084. 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.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director 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):
Device Name: QUANTA Plex™ ENA Profile 6
Indications For Use:
The QUANTA Plex™ ENA Profile 6 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70 and Jo-1 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren's syndrome, scleroderma and polymyositis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRHaOffice of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K031458 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ (Per 21 CFR 801.109) |
|---|---|
| ------------------ | ---------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
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