(89 days)
Not Found
Not Found
No
The summary describes a latex slide test kit for detecting rheumatoid factor, which is a traditional laboratory method and does not mention any AI or ML components.
No
The device is described as a diagnostic tool for detecting a marker of rheumatoid arthritis, not for treating the condition.
Yes
The Intended Use / Indications for Use section states that the device "is intended to be used as an aid in the diagnosis of rheumatoid arthritis," which is a diagnostic purpose.
No
The device description explicitly states the device is a "test kit" comprised of physical components like "RF Latex Reagent, RF Positive Control. Negative Control and Glycine/Saline Buffer". This indicates it is a hardware-based diagnostic test, 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 it's for the "qualitative and semi-quantitative detection of rheumatoid factor in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body).
- Device Description: The device is a "test kit" comprised of reagents and controls used to perform a test on a biological sample.
- Aid in Diagnosis: The intended use also states it's an "aid in the diagnosis of rheumatoid arthritis," which is a common purpose of IVD devices.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RaPET® RF is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
Product codes
82DHR
Device Description
The device test kit is comprised of RF Latex Reagent, RF Positive Control. Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing.
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)
Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.998 and a regression equation of Y=1.003X - 2.82.
In addition, precision, sensitivity, specificity, and interference studies were performed on RaPET® RF. Results of these tests were found to be acceptable.
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
§ 866.5775 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
510(k) Summarv RaPET® RF
FEB 17 1998
Submitter's Name Kirk Johnson Stanbio Laboratory. Inc. 2930 East Houston Street San Antonio, TX 78202
Tel. (210) 222-2108 Fax (210) 227-6367
Prepared By Kirk Johnson November 14, 1997
Product Name Trade Name: RaPET® RF Common Name: Rheumatoid Factor Test Classification Number: 82DHR
Description of Device
The device test kit is comprised of RF Latex Reagent, RF Positive Control. Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing.
Intended Use of Device
RaPET® RF is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
Comparison of Devices
Both RF latex methods employ latex beads coated with human gamma alobulin which agalutinate in the presence rheumatoid arthritis serum.
Performance Data
Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.998 and a regression equation of Y=1.003X - 2.82.
In addition, precision, sensitivity, specificity, and interference studies were performed on RaPET® RF. Results of these tests were found to be acceptable.
ORATORY, INC.
ston Street
on Antonio, Texas 78202
(210) 222-2108
-800-531-5535
AX (210) 227-6367
mp://www.stanbio.com
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kirk Johnson Quality Assurance Manager Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202
FEB 1 7 1998
Re: K974370 Trade Name: RaPET RF Regulatory Class: II Product Code: DHR 82 November 18, 1997 Dated: November 20, 1997 Received:
Dear Mr. Johnson:
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 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 requlations.
2
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
3
Page 1 of 19
| 510(k) Number (if known): | K974370 |
|---|---|
| --------------------------- | --------- |
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
RaPET RF (Class II) is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
Peter E. Makim
(Division Sign-Off)
Division of Clinical Laboratory Devices K974370
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use_ (Per 21 CFR 801.109)
:
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)