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 Description

ColorSlide® RF is a rapid latex particle agglutination assay for the determination of circulating Rheumatoid Factors (RF) in human serum.

AI/ML Overview

The provided text describes the Seradyn ColorSlide® RF device and its performance in comparison to predicate devices, SeraTest™ RF and Behring's Rapitex RF.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, and efficiency. Instead, it states that "An acceptable correlation was obtained between the two tests" (ColorSlide® RF vs. SeraTest™ RF and ColorSlide® RF vs. RapiTex RF). The reported performance values are:

Comparison to SeraTest™ RF (Qualitative Assay)

Metric	Reported Performance
Relative Sensitivity	100%
Relative Specificity	97.9%
Positive Predictive Value	98.2%
Negative Predictive Value	100%
Efficiency of Test	99.03%

Comparison to RapiTex RF (Qualitative Assay)

Metric	Reported Performance
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 Agreement

Comparison	Agreement Type	Reported Performance (ColorSlide® RF vs. SeraTest™ RF)	Reported Performance (ColorSlide® RF vs. RapiTex RF)
Complete Agreement	Exact Titer	28.6% (16/56 samples)	47.37% (63/133 samples)
+/- One Dilution	Within one titer	55.4% (31/56 samples)	48.12% (64/133 samples)
> One Dilution		16.1% (9/56 samples)	4.5% (6/133 samples)

Lot-to-Lot Reproducibility: All titers fell within one doubling dilution, indicating satisfactory performance with little or no lot-to-lot variability.

Sensitivity based on international standard: Approximately 20 IU/mL, traceable to a WHO reference serum.

Passive Interference: No adverse interference from hemoglobin (at 1000 mg/dL), bilirubin (at 40 mg/dL), or lipid (at 20 g/L).

Stability Data: Performance within specifications for approximately 400 days for one ColorSlide® RF lot, with ongoing studies for at least two years.

2. Sample Size Used for the Test Set and Data Provenance

Comparison to SeraTest™ RF:
- Sample Size: 103 patient samples.
- Data Provenance: Testing was conducted at one site. The country of origin is not specified but is implicitly the USA, given the company's address and the FDA 510(k) submission. It's a retrospective comparison study, as patient samples were tested by both methods.
Comparison to Behring's RapiTex RF:
- Sample Size: 309 patient samples.
- Data Provenance: Testing was conducted at three sites. Country of origin implicitly USA. Retrospective comparison study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The studies compare the ColorSlide® RF device to two legally marketed predicate devices (SeraTest™ RF and RapiTex RF). The ground truth for sensitivity and specificity is established by the results of these predicate devices. The document does not mention the involvement of "experts" in establishing a separate ground truth or their qualifications. The readings of the agglutination reactions for both the ColorSlide® RF and the predicate devices are "read visually," implying trained laboratory personnel but no specifically defined "experts" for ground truth establishment.

4. Adjudication Method for the Test Set

No explicit adjudication method is described. The comparison is made directly between the results of the ColorSlide® RF and the predicate device. For the semi-quantitative assay, agreement is categorized. There is no mention of a process like 2+1 or 3+1 for resolving discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document does not describe human readers using AI assistance or measuring its effect size. The device is a diagnostic assay, not an AI software.

6. Standalone (Algorithm Only) Performance

The device is a laboratory assay (latex agglutination test), not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. Its performance is inherent in the chemical and physical reaction, read visually by laboratory personnel.

7. Type of Ground Truth Used

The ground truth for the performance assessment (sensitivity, specificity, predictive values) is established by the results of the predicate devices (Seradyn's SeraTest™ RF and Behring's Rapitex RF). For the semi-quantitative assays, the ground truth for agreement is also based on the titers obtained from the predicate devices. The document does not mention pathology, outcomes data, or expert consensus as primary ground truth references for the clinical performance assessment.

8. Sample Size for the Training Set

This information is not applicable. The ColorSlide® RF is a latex agglutination assay, not an AI or machine learning algorithm that requires a "training set." Its development would involve chemical and manufacturing processes, and its characteristics are assessed against established methods, not by training.

9. How the Ground Truth for the Training Set was Established

As mentioned above, there is no "training set" in the context of an AI/ML algorithm. Therefore, this question is not applicable to the ColorSlide® RF device. The assay development would have involved validation against known positive and negative samples, but these are part of R&D and not typically referred to as a "training set" in this context.

Summary

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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

1. Device Name:
- ColorSlide® RF a. Proprietary Name:
- Rheumatoid Factors (RF), Latex Agglutination Test b. Common Name:
- Rheumatoid Factor, System, Test c. Classification Name:
1. 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.

1. Description of Device:
  ColorSlide® RF is a rapid latex particle agglutination assay for the determination of circulating Rheumatoid Factors (RF) in human serum.

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6. Intended Use:

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 theparticle.	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 positivesamples.	Requires that all positive samples beconfirmed at a 1:20 dilution.

8. Summary of Non-clinical Testing:

NONE

1. 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.

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	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%

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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:

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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:

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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).