← Product Code [DHR](/productcode/DHR) · K981496 # COLOR-SLIDE RF (K981496) _Seradyn, Inc. · DHR · Jun 15, 1998 · Immunology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K981496 ## Device Facts - **Applicant:** Seradyn, Inc. - **Product Code:** [DHR](/productcode/DHR.md) - **Decision Date:** Jun 15, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5775 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The test provides qualitative and semi-quantitative determination of rheumatoid factors (RF) in human serum. The test provides results for one of the seven criteria used in the diagnosis of rheumatoid arthritis as suggested by the American College of Rheumatology ## Device Story ColorSlide RF is a manual, rapid latex particle agglutination assay for detecting rheumatoid factors (RF) in human serum. The device utilizes latex particles dyed blue and coated with human IgG as the solid phase matrix. When mixed with patient serum containing RF, the particles undergo agglutination. The reaction is read visually by a clinician in a laboratory setting. The test serves as a screening tool and provides one of the seven criteria for diagnosing rheumatoid arthritis. It is intended for prescription use. The device provides qualitative results and can be used semi-quantitatively to determine titers. It offers a diagnostic aid to healthcare providers, facilitating the clinical assessment of patients suspected of having rheumatoid arthritis. ## Clinical Evidence Clinical testing compared ColorSlide RF against SeraTest RF (103 samples) and RapiTex RF (309 samples). For SeraTest RF, relative sensitivity was 100%, specificity 97.9%, and efficiency 99.03%. For RapiTex RF, relative sensitivity was 97.69%, specificity 98.32%, and efficiency 98.06%. Semi-quantitative agreement showed high correlation with titers falling within one doubling dilution. Passive interference studies showed no adverse effects from hemoglobin, bilirubin, or lipids. Lot-to-lot reproducibility was satisfactory. ## Technological Characteristics Manual latex agglutination assay. Components: blue-dyed latex particles covalently coupled with human IgG. Principle: visual detection of agglutination reaction. No energy source required. Standalone diagnostic test. ## Regulatory 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. ## Predicate Devices - SeraTest™ RF - Behring's RapiTex RF ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ KG81496 Jun 1 5 1998 Image /page/0/Picture/2 description: The image shows the logo for Seradyn, a subsidiary of Mitsubishi Chemical Corporation. The logo features a stylized globe with a swoosh around it, placed above the company name "Seradyn" in a bold, slightly italicized font. Below the name, the text "A Subsidiary of Mitsubishi Chemical Corporation" is printed in a smaller font size. The logo is in black and white. 1200 Madison Avenue  •  Indianapolis IN 46225 USA 317-266-2000 ・ Fax: 317-266-2991 www.seradyn.com # 510(k) Summary [As Required by 21 CFR 807.92 (c)] 1. Company/contact person: Seradyn, Inc. 1200 Madison Avenue Indianapolis, IN 46225 Establishment registration No: 1819246 Martin J. Weinstein Vice President, Manufacturing and Regulatory Affairs Telephone: (317) 266-2941 Fax: (317) 266-2991 #### 2. Prepared: April 24, 1998 - 3. Device Name: - ColorSlide® RF a. Proprietary Name: - Rheumatoid Factors (RF), Latex Agglutination Test b. Common Name: - Rheumatoid Factor, System, Test c. Classification Name: - 4. Legally marketed devices to which equivalency is claimed: Seradyn ColorSlide® RF is substantially equivalent to both Seradyn's SeraTest™ RF and Behring's Rapitex RF. - 5. Description of Device: ColorSlide® RF is a rapid latex particle agglutination assay for the determination of circulating Rheumatoid Factors (RF) in human serum. {1}------------------------------------------------ #### 6. Intended Use: The test provides qualitative and semi-quantitative determination of rheumatoid factors (RF) in human serum. The test provides results for one of the seven criteria used in the diagnosis of rheumatoid arthritis as suggested by the American College of Rheumatology ### 7. Comparison of Technological Characteristics: Both ColorSlide® RF and SeraTest™ RF are non-automated manual tests employing latex particles coated with human IgG as the solid phase matrix. As such, both systems have similar technological characteristics. There are no major differences in technology. The agglutination reaction (or the absence thereof) in both cases is read visually. Like SeraTest™ RF, ColorSlide® RF is intended as a screening test for rheumatoid factors. Both latex tests can be used semi-quantitatively for the determination of circulating rheumatoid factors in human serum. Differences between the two assays are listed in the following table: | ColorSlide® RF | SeraTest™ RF | |-------------------------------------------------------|------------------------------------------------------------------------| | Human IgG is covalently coupled to the
particle. | Human IgG is absorbed by the particle
(process change). | | Latex particle has been dyed blue. | The latex particle is naturally white. | | Requires no retesting to confirm positive
samples. | Requires that all positive samples be
confirmed at a 1:20 dilution. | ### 8. Summary of Non-clinical Testing: NONE - 9. Summary of Clinical Testing: - A. Comparison to SeraTest™ RF Testing was conducted at one site. A total of 103 patient samples were tested by both ColorSlide® RF and SeraTest™ RF. ## Qualitative Assay: The results of the qualitative procedure are summarized in the following table. An acceptable correlation was obtained between the two tests. {2}------------------------------------------------ | | ColorSlide RF + | ColorSlide RF - | Total | |----------------|-----------------|-----------------|-------| | SeraTest™ RF + | 55 | 0 | 55 | | SeraTest™ RF - | 1 | 47 | 48 | | Total | 56 | 47 | 103 | | Relative Sensitivity: | 100% | |----------------------------|--------| | Relative Specificity: | 97.9% | | Positive Predictive Value: | 98.2% | | Negative Predictive Value: | 100% | | Efficiency of Test: | 99.03% | # Semi-Quantitative Assay: The titers of the 133 positive samples were determined. An acceptable The titers of the 133 positive Samples were dotominound in the first of the results are summarized in the following table. | Agreement | Number of Samples | Percentage | |------------------|-------------------|------------| | Agreement | 16 | 28.6% | | Complete | 31 | 55.4% | | +/- One Dilution | 9 | 16.1% | | > One Dilution | | | | Total | 56 | | # B. Comparison to Behring's Testing was conducted at three sites. A total of 309 patient samples were tested ed the same of the capit Dr. Tou RE 103thig was - Slide® RF and RapiTex RF. # Qualitative Assay: The results of the qualitative procedure are summarized in the following table. An a The results of the qualitative prosoually and the two tests. | | ColorSlide RF + | ColorSlide RF - | Total | |--------------|-----------------|-----------------|-------| | RapiTex RF + | 127 | 3 | 130 | | RapiTex RF - | 3 | 176 | 179 | | Total | 130 | 179 | 309 | | Relative Sensitivity: | 97.69% | |----------------------------|--------| | Relative Specificity: | 98.32% | | Positive Predictive Value: | 97.69% | | Negative Predictive Value: | 98.32% | | Efficiency of Test: | 98.06% | {3}------------------------------------------------ ## Semi-Quantitative Assay: The titers of the 133 positive samples were determined. An acceptable correlation was obtained between the two tests. The results are summarized in the following table. | Agreement | Number of Samples | Percentage | |------------------|-------------------|------------| | Complete | 63 | 47.37% | | +/- One Dilution | 64 | 48.12% | | > One Dilution | 6 | 4.5% | | Total | 133 | | - C. Lot-to-Lot Comparison Study The reproducibility of three lots made on different days was compared. A panel of 6 patients serum (3 positive and 3 negative) was assayed with all three lots. Positive controls and positive serum were titered to an end point. Kits from all three lots performed satisfactorily with little or no lot-to-lot variability. All titers fell within one doubling dilution. - D. Sensitivity based on an international standard Sensitivity based on the first British Standard (64/2) for Rheumatoid Arthritis Serum (traceable to a WHO reference serum) was approximately 20 IU/mL. - E. Passive Interference Study Hemoglobin (at 1.000 mq/dL), or bilirubin (at 40 mg/dL) or lipid (at 20 g/L) in serum did not adversely interfere with the assay. ## F. Stability Data Current stability data for SeraTest™ RF goes out beyond 15 months. One development lot of ColorSlide® RF was monitored for approximately 400 days. Performance was within specifications. Three stability studies are currently in progress. The product is being stored in accordance with label copy. These studies will be continued for at least two vears. Product expiration dating will be based on data available to Seradyn at the time of manufacture. {4}------------------------------------------------ # 10. Conclusions: ್ಯಾ The results of clinical testing demonstrate that the performance and effectiveness of the ColorSlide® RF test are substantially equivalent to those of Seradyn's SeraTest™ RF and Behring's RapiTex RF. . 4-2 11. Other Information: None {5}------------------------------------------------ Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. # JUN 1 5 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Martin J. Weinstein Vice President, Manufacturing and Requlatory Affairs Seradyn, Inc. 1200 Madison Avenue Indianapolis, Indiana 46225 Re : K981496 ColorSlide® RF Trade Name: Regulatory Class: II Product Code: DHR Dated: April 24, 1998 Received: April 27, 1998 Dear Mr. Weinstein: 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, Druq, 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, labelinq, 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation may result in regulatory 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 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 Regulations. {6}------------------------------------------------ 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 Butman 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 {7}------------------------------------------------ Page lof l | 510(k) Number (if known): | K981496 | |---------------------------|-----------------------------| | Device Name: | Color Slide e RF | # Indications For Use: The test provides qualitative and semi-quantitative determination of rheumatoid factors (RF) in human serum. The test provides results for one of the seven criteria used in the diagnosis of rheumatoid arthritis as suggested by the American College of Rheumatology Peter E. Mackin (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) **Prescription Use** (Per 21 CFR 801.109) , OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K981496](https://fda-staging.innolitics.com/device/K981496) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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