(62 days)
Not Found
Not Found
No
The summary describes a standard ELISA assay, which is a biochemical test and does not involve AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as an aid in diagnosis and not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "an aid in the diagnosis of rheumatoid arthritis (RA)," which directly indicates its diagnostic purpose.
No
The device described is an ELISA kit, which is a laboratory assay involving physical reagents and procedures, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is for the "detection of IgG rheumatoid factor (RF) antibodies in patient sera" and is an "aid in the diagnosis of rheumatoid arthritis (RA)". This clearly indicates that the device is intended to be used on samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description as an "enzyme-linked immunosorbent assay (ELISA)" further confirms that it is a laboratory test performed on biological samples.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
QUANTA Lite™ RF IgG ELISA is a semiquantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG rheumatoid factor (RF) 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 rheumatoid arthritis (RA).
Product codes
DHR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.
4 1998 NOV
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Brys C. Myers Manager, Requlatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234
Re : K983083 Trade Name: QUANTA Lite™ RF IgG ELISA Requlatory Class: II Product Code: DHR Dated: September 2, 1998 Received: September 3, 1998
Dear Mr. Myers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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
.
2
Page 5 of 32
510(k) Number (if known):
Device Name: QUANTA Lite™ RF IQG ELISA
Indications For Use:
QUANTA Lite™ RF IgG ELISA is a semiquantitative enzyme-The linked immunosorbent assay (ELISA) for the detection of IgG rheumatoid factor (RF) 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 rheumatoid arthritis (RA).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tita E. Masini
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K982883
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)