(49 days)
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No
The device description and performance studies describe a traditional latex particle agglutination assay, with no mention of AI or ML terms or concepts.
No
The device is an in-vitro diagnostic test used to determine rheumatoid factors; it aids in diagnosis but does not provide therapy.
Yes.
The device provides qualitative and semi-quantitative determination of rheumatoid factors (RF) which are used as one of the criteria in the diagnosis of rheumatoid arthritis.
No
The device description explicitly states it is a "rapid latex particle agglutination assay," which is a physical test kit involving reagents and a reaction, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test provides qualitative and semi-quantitative determination of rheumatoid factors (RF) in human serum. This is a biological sample taken from the human body.
- Device Description: The device is described as a "rapid latex particle agglutination assay for the determination of circulating Rheumatoid Factors (RF) in human serum." This describes a test performed in vitro (outside the body) on a biological sample.
- Performance Studies: The performance studies involve testing "patient samples" and comparing results to other similar tests, which is typical for IVD devices.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This device clearly fits that description.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
DHR
Device Description
ColorSlide® RF is a rapid latex particle agglutination assay for the determination of circulating Rheumatoid Factors (RF) in human serum.
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
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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
A total of 103 patient samples were tested by both ColorSlide® RF and SeraTest™ RF. Testing was conducted at one site. A total of 309 patient samples were tested by ColorSlide® RF and RapiTex RF. Testing was conducted at three sites.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to SeraTest™ RF: Qualitative Assay (N=103) showed Relative Sensitivity: 100%, Relative Specificity: 97.9%, Positive Predictive Value: 98.2%, Negative Predictive Value: 100%, Efficiency of Test: 99.03%.
Semi-Quantitative Assay (N=56 positive samples): Complete Agreement: 28.6%, +/- One Dilution Agreement: 55.4%, > One Dilution Agreement: 16.1%.
Comparison to Behring's Rapitex RF: Qualitative Assay (N=309) showed Relative Sensitivity: 97.69%, Relative Specificity: 98.32%, Positive Predictive Value: 97.69%, Negative Predictive Value: 98.32%, Efficiency of Test: 98.06%.
Semi-Quantitative Assay (N=133 positive samples): Complete Agreement: 47.37%, +/- One Dilution Agreement: 48.12%, > One Dilution Agreement: 4.5%.
Lot-to-Lot Comparison Study: Panel of 6 patient serum (3 positive and 3 negative) assayed with three lots. All titers fell within one doubling dilution.
Sensitivity based on an international standard: Approximately 20 IU/mL, traceable to a WHO reference serum.
Passive Interference Study: Hemoglobin (1000 mg/dL), bilirubin (40 mg/dL), or lipid (20 g/L) did not adversely interfere.
Stability Data: One development lot monitored for approximately 400 days, performance within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 100%, Relative Specificity: 97.9%, Positive Predictive Value: 98.2%, Negative Predictive Value: 100%, Efficiency of Test: 99.03% (Comparison to SeraTest™ RF, Qualitative Assay).
Relative Sensitivity: 97.69%, Relative Specificity: 98.32%, Positive Predictive Value: 97.69%, Negative Predictive Value: 98.32%, Efficiency of Test: 98.06% (Comparison to Behring's Rapitex RF, Qualitative Assay).
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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
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)]
- 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
-
- Device Name:
- ColorSlide® RF a. Proprietary Name:
- Rheumatoid Factors (RF), Latex Agglutination Test b. Common Name:
- Rheumatoid Factor, System, Test c. Classification Name:
-
- 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.
-
- Description of Device:
ColorSlide® RF is a rapid latex particle agglutination assay for the determination of circulating Rheumatoid Factors (RF) in human serum.
- Description of Device:
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
-
- 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.
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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
- Other Information:
None
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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.
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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
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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)