(36 days)
Not Found
No
The device description details a standard immunoturbidimetric assay with results determined by interpolation from a calibration curve, which does not involve AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
No
This device is an in vitro diagnostic assay used for the quantitative determination of rheumatoid factor in human serum to aid in the diagnosis of rheumatoid arthritis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that "Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis," clearly indicating a diagnostic purpose.
No
The device is an in vitro diagnostic assay that involves a chemical reaction and detection of absorbance change, indicating it is a hardware-based laboratory test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitation of rheumatoid factor in human serum and may aid in the diagnosis of rheumatoid arthritis. This clearly indicates it's used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The "Device Description" further clarifies that it is an in vitro diagnostic assay for the quantitative determination of rheumatoid factor in human serum.
- Methodology: The description of the latex enhanced immunoturbidimetric assay, which involves an antigen-antibody reaction in a sample, is a typical methodology used in in vitro diagnostics.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rheumatoid Factor assay is used for the quantitation of rheumatoid factor in human serum. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
Product codes
DHR
Device Description
Rheumatoid Factor is an in vitro diagnostic assay for the quantitative determination of rheumatoid factor in human serum. The RF assay is a latex enhanced immunoturbidimetric assay that involves an antigen-antibody reaction between the rheumatoid factor in the sample and the denatured human IgG, which has been adsorbed to latex particles. The resulting agglutination is detected as an absorbance change (572 nm), with the magnitude of the change being proportional to the quantity of RF in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.
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
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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)
Comparative performance studies were conducted using the AEROSET® System. The Rheumatoid Factor assay method comparison yielded acceptable correlation with the Roche Diagnostics Corp. Tina-quant RF II assay on the Hitachi 717 Analyzer. On the AEROSET System, the correlation coefficient = 0.996, slope = 1.14, and the Y-intercept = 2.14 IU/mL. Precision studies were conducted using the Rheumatoid Factor assay. Within-run, between-run, and between-day studies were performed using three levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 4.6% to 7.5%, Level 2 ranged from 3.6% to 4.3%, and Level 3 ranged from 1.2% to 2.0%. The Rheumatoid Factor assay range is 4.8 to 200.0 IU/mL. The limit of quantitation (sensitivity) of the Rheumatoid Factor assay is 7.71 IU/mL on the AEROSET System. These data demonstrate that the performance of the Rheumatoid Factor assay is substantially equivalent to the performance of the Roche Diagnostics Corp. Tina-quant RF II assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.996, slope = 1.14, Y-intercept = 2.14 IU/mL, total %CV for Level 1 ranged from 4.6% to 7.5%, Level 2 ranged from 3.6% to 4.3%, Level 3 ranged from 1.2% to 2.0%, assay range is 4.8 to 200.0 IU/mL, limit of quantitation (sensitivity) of the Rheumatoid Factor assay is 7.71 IU/mL
Predicate Device(s)
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) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, TX 75038
Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | December 5, 2002 |
|---|---|
| Device Trade or Proprietary Name: | Rheumatoid Factor |
| Device Common/Usual Name or Classification Name: | Rheumatoid Factor |
| Classification Number/Class: | DHR, Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K024067
Test Description:
Rheumatoid Factor is an in vitro diagnostic assay for the quantitative determination of rheumatoid factor in human serum. The RF assay is a latex enhanced immunoturbidimetric assay that involves an antigen-antibody reaction between the rheumatoid factor in the sample and the denatured human IgG, which has been adsorbed to latex particles. The resulting agglutination is detected as an absorbance change (572 nm), with the magnitude of the change being proportional to the quantity of RF in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.
Rheumatoid Factor 510(k) 1/9/2003 RF Summary R2.doc
Section III Page 1
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Substantial Equivalence:
The Rheumatoid Factor assay is substantially equivalent to the Roche Diagnostics Corp. Tina-quant RF II assay (K002609) on the Hitachi® 717 Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro immunoassays.
- Both assays can be used for the quantitative determination of rheumatoid factor. .
- . Both assays yield similar clinical results.
- Both assays are based on the measurement of the agglutination following . antigen-antibody reaction.
- . Human serum is a suitable specimen for both assays.
Differences:
- . There is a difference between the assay range.
- . Suitable specimens for the Roche Diagnostics Corp. Tina-quant RF II assay include plasma specimens.
Intended Use:
The Rheumatoid Factor assay is used for the quantitation of rheumatoid factor in human serum.
Section II Page 2
Image /page/1/Picture/16 description: The image shows the number 000013 in a bold, sans-serif font. The numbers are black against a white background. The numbers are evenly spaced and aligned horizontally.
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Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Rheumatoid Factor assay method comparison yielded acceptable correlation with the Roche Diagnostics Corp. Tina-quant RF II assay on the Hitachi 717 Analyzer. On the AEROSET System, the correlation coefficient = 0.996, slope = 1.14, and the Y-intercept = 2.14 IU/mL. Precision studies were conducted using the Rheumatoid Factor assay. Within-run, between-run, and between-day studies were performed using three levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 4.6% to 7.5%, Level 2 ranged from 3.6% to 4.3%, and Level 3 ranged from 1.2% to 2.0%. The Rheumatoid Factor assay range is 4.8 to 200.0 IU/mL. The limit of quantitation (sensitivity) of the Rheumatoid Factor assay is 7.71 IU/mL on the AEROSET System. These data demonstrate that the performance of the Rheumatoid Factor assay is substantially equivalent to the performance of the Roche Diagnostics Corp. Tina-quant RF II assay on the Hitachi 717 Analyzer.
Conclusion:
The Rheumatoid Factor assay is substantially equivalent to the Roche Diagnostics Corp. Tina-quant RF II assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 5 2003
Ms. Linda Morris Senior Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re: K024067
Trade/Device Name: Rheumatoid Factor Regulation Number: 21 CFR § 866.5775 Regulation Name: System, Test, Rheumatoid Factor Regulatory Class: II Product Code: DHR Dated: December 5, 2002 Received: December 10, 2002
Dear Ms. Morris:
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 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.
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Page 2
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). 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). 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 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): HOAYOLe7
Device Name: Rheumatoid Factor ------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications For Use:
The Rheumatoid Factor assay is used for the quantitation of rheumatoid factor in human serum. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Af. Reeves for J. Bautista
linical Laborato
Rheumatoid Factor 510(k) 1 2/5/2002 RF_5_R1.doc