K Number
K952802
Device Name
VISUWELL REAGIN II
Date Cleared
1996-05-23

(339 days)

Product Code
Regulation Number
866.3820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies as a screening test in syphilis serology. It is not intended for use in screening blood or plasma donors.
Device Description
Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies in syphills serology. In this device, serum is incubated with a mixture of cardiolipin, lecithin, cholesterol dried to a polystyrene solid phase. Antilipid antibodies react with the lipoidal antigen to form an immune complex. The presence of non-treponemal complexed antibodies is detected with a monoclonal anti-human lgG-peroxidase conjugate. The presence of bound conjugate is detected by the addition of enzyme substrate and subsequent development of colour. The reaction is stopped by the addition of acid and colour intensity is determined spectrophotometrically at 450 nm. Test results are interpreted relative to a floating cutoff based on the negative control. Positive and negative controls are used for establishing test validity.
More Information

Not Found

Venereal Disease Research Laboratory (VDRL) Slide Test, Rapid Plasma Reagin (RPR) Card Test, Reagin Screen Test (RST)

No
The device description details a standard enzyme-linked immunosorbent assay (ELISA) which relies on chemical reactions and spectrophotometric measurement, not AI/ML. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML devices.

No.
The device is an in vitro diagnostic (IVD) test for the qualitative detection of antibodies, which is used for screening and diagnosis, not for treating a disease.

Yes

Explanation: The "Intended Use / Indications for Use" section states that the device is "for the in vitro qualitative detection of non-treponemal (reagin) antibodies as a screening test in syphilis serology," which indicates its use in diagnosing a medical condition.

No

The device description clearly outlines a laboratory-based enzyme-linked immunosorbent assay (ELISA) which involves physical reagents, incubation steps, and spectrophotometric measurement, indicating it is a hardware-based in vitro diagnostic device, not software-only.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies as a screening test in syphilis serology."

The term "in vitro" is a key indicator that the device is intended for use outside of a living organism, typically in a laboratory setting, to examine specimens such as blood or serum. This aligns with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies as a screening test in syphilis serology. It is not intended for use in screening blood or plasma donors.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies in syphills serology. In this device, serum is incubated with a mixture of cardiolipin, lecithin, cholesterol dried to a polystyrene solid phase. Antilipid antibodies react with the lipoidal antigen to form an immune complex. The presence of non-treponemal complexed antibodies is detected with a monoclonal anti-human lgG-peroxidase conjugate. The presence of bound conjugate is detected by the addition of enzyme substrate and subsequent development of colour. The reaction is stopped by the addition of acid and colour intensity is determined spectrophotometrically at 450 nm.

Test results are interpreted relative to a floating cutoff based on the negative control. Positive and negative controls are used for establishing test validity.

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)

To demonstrate substantial equivalence, Visuwell® Reagin was compared to the reference tests in specificity, sensitivity, predictive values, cross-reactivity and overall agreement of test results.

Specificity Comparison: Specificity results were obtained from 10,738 specimens in random, low-risk and high-risk populations. The specificity of Visuwell® Reagin II was 97.1% compared to the 99.5% specificity of the reference non-treponemal tests.

Sensitivity Comparison: Sensitivity results were obtained from the specimens of 306 patients with untreated syphilis, 74 patients whose treatment status was unknown and 325 patients with treated syphilis.
Visuwell® Reagin II was reactive with 92.2% of specimens from patients with untreated syphilis as compared to 95.8% of specimens with the reference tests. Where treatment status of the patients was unknown, Visuwell® Reagin II was reactive with 93.2% of the specimens as compared to 82.4% of the specimens with the reference tests. Visuwell® Reagin II was reactive with 75.4% of specimens from patients with treated syphilis as compared to 90.2% of the specimens with the reference tests.
Visuwell® Reagin II is substantially equivalent to reference non-treponemal tests in the detection of non-treponemal antibody in sera of patients with untreated syphilis. Visuwell® Reagin II shows lower reactivity with sera from patients with treated syphilis which may suggest potential for monitoring response to therapy.

Predictive Values: The predictive values of positive for syphilis in Visuwell® Reagin II and the reference tests were determined for the Sexually Transmitted Disease (STD) population. The predictive values of negative were determined with data from all sites. The predictive value of positive for Visuwell® Reagin II was 97.4% as compared to 99.4% for the reference tests. The predictive value of negative for Visuwell® Reagin II was 99.0% as compared to 99.5% for the reference tests.

Cross-Reactivity: Cross-Reactivity results were obtained from 151 specimens consisting of specimens from individuals with a variety of bacterial, viral and auto-immune disorders. Specimens identified as syphilis biological false-positives and specimens from conditions frequently associated with false reactivity in non-treponemal screen tests such as pregnancy and drug abuse were included in these results.
The specificity of Visuwell® Reagin II in the clinical population characterized by non-syphilitic diseases or conditions was 86.8% as compared to 91.9% with the reference tests.

Overall Agreement: The overall agreement between the Visuwell® Reagin II and the reference tests results for all sera (11,443 specimens) was 96.5%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Specificity of Visuwell® Reagin II was 97.1% compared to 99.5% of reference tests.
Sensitivity for untreated syphilis: Visuwell® Reagin II 92.2% vs. reference tests 95.8%.
Sensitivity for unknown treatment status: Visuwell® Reagin II 93.2% vs. reference tests 82.4%.
Sensitivity for treated syphilis: Visuwell® Reagin II 75.4% vs. reference tests 90.2%.
Predictive value of positive for STD population: Visuwell® Reagin II 97.4% vs. reference tests 99.4%.
Predictive value of negative: Visuwell® Reagin II 99.0% vs. reference tests 99.5%.
Cross-reactivity specificity in clinical population with non-syphilitic diseases: Visuwell® Reagin II 86.8% vs. reference tests 91.9%.
Overall agreement: 96.5%.

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.

Not Found

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.

Venereal Disease Research Laboratory (VDRL) Slide Test, Rapid Plasma Reagin (RPR) Card Test, Reagin Screen Test (RST)

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).

Not Found

§ 866.3820

Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).

0

K952802

Image /page/0/Picture/1 description: The image shows the logo for "BIOMIRA DIAGNOSTICS INC.". The word "BIOMIRA" is in a bold, sans-serif font and is set against a black background. Below that, "DIAGNOSTICS INC." is in a smaller, sans-serif font and is set against a white background. The text is all in uppercase.

MAY 2 3 1996 510(k) SUMMARY VISUWELL® REAGIN II

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safety Medical Devices Act of 1990.

Submitter:

BIOMIRA Diagnostics Inc. 30 Meridian Rd. Rexdale, Ontario M9W 4Z7 Contact: Ms. Althea R. Lawrence, Director, Quality/Regulatory

Date Submitted:

June 16, 1995

Device Name:

Trade Name: Visuwell® Reagin II

Common Name:

Syphilis non-treponemal antibody detection kit

Classification Name: Treponemal pallidum non-treponemal test reagent, Class II

Device Description:

Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies in syphills serology. In this device, serum is incubated with a mixture of cardiolipin, lecithin, cholesterol dried to a polystyrene solid phase.

PAGE 1 OF 5

1

Image /page/1/Picture/0 description: The image shows the logo for "BIOMIRA DIAGNOSTICS INC." The word "BIOMIRA" is in large, bold, sans-serif font, set against a black background. Below this, "DIAGNOSTICS INC." is printed in a smaller, sans-serif font. The overall design is simple and professional, likely representing a company in the diagnostics field.

Antilipid antibodies react with the lipoidal antigen to form an immune complex. The presence of non-treponemal complexed antibodies is detected with a monoclonal anti-human lgG-peroxidase conjugate. The presence of bound conjugate is detected by the addition of enzyme substrate and subsequent development of colour. The reaction is stopped by the addition of acid and colour intensity is determined spectrophotometrically at 450 nm.

Test results are interpreted relative to a floating cutoff based on the negative control. Positive and negative controls are used for establishing test validity.

Intended Use

Visuwell® Reagin II is an enzyme-linked immunosorbent assay for the in vitro qualitative detection of non-treponemal (reagin) antibodies as a screening test in syphilis serology. It is not intended for use in screening blood or plasma donors.

Substantial Equivalence Claim

Visuwell® Reagin II was demonstrated to be substantially equivalent in performance to the following legally marketed reference non-treponemal tests:

Venereal Disease Research Laboratory (VDRL) Slide Test Rapid Plasma Reagin (RPR) Card Test Reagin Screen Test (RST)

Visuwell® Reagin II has the same intended use for screening in svphilis serology but different technological characteristics than the above mentioned reference tests. These tests employ lipoidal antigen comprised of cardiolipin, lecithin and cholesterol.

PAGE 2 OF 5

2

Image /page/2/Picture/0 description: The image shows the logo for Biomira Diagnostics Inc. The word "BIOMIRA" is in large, bold, white letters on a black background. Below that, the words "DIAGNOSTICS INC." are in smaller, white letters on a white background.

Results in the reference tests are interpreted subjectively according to the presence or absence of flocculation as opposed to the objective spectrophotometric interpretation of results using Visuwell® Reagin II.

To demonstrate substantial equivalence, Visuwell® Reagin was compared to the reference tests in specificity, sensitivity, predictive values, cross-reactivity and overall agreement of test results.

Specificity Comparison

Specificity results were obtained from 10,738 specimens in random, low-risk and high-risk populations. The specificity of Visuwell® Reagin II was 97.1% compared to the 99.5% specificity of the reference non-treponemal tests. Visuwell® Reagin II is substantially equivalent to non-treponemal reference tests in specificity.

Sensitivity Comparison

Sensitivity results were obtained from the specimens of 306 patients with untreated syphilis, 74 patients whose treatment status was unknown and 325 patients with treated syphilis.

Visuwell® Reagin II was reactive with 92.2% of specimens from patients with untreated syphilis as compared to 95.8% of specimens with the reference tests. Where treatment status of the patients was unknown, Visuwell® Reagin II was reactive with 93.2% of the specimens as compared to 82.4% of the specimens with the reference tests. Visuwell® Reagin II was reactive with 75.4% of specimens from patients with treated syphilis as compared to 90.2% of the specimens with the reference tests.

PAGE 3 OF 5

3

Image /page/3/Picture/0 description: The image shows the logo for Biomira Diagnostics Inc. The word "BIOMIRA" is in large, bold, white letters on a black background. Below that, the words "DIAGNOSTICS INC." are in smaller, black letters.

Therefore, Visuwell® Reagin II is substantially equivalent to reference nontreponemal tests in the detection of non-treponemal antibody in sera of patients with untreated syphilis. Visuwell® Reagin II shows lower reactivity with sera from patients with treated syphilis which may suggest potential for monitoring response to therapy.

Predictive Values

The predictive values of positive for syphilis in Visuwell® Reagin II and the reference tests were determined for the Sexually Transmitted Disease (STD) population. The predictive values of negative were determined with data from all sites. The predictive value of positive for Visuwell® Reagin II was 97.4% as compared to 99.4% for the reference tests. The predictive value of negative for Visuwell® Reagin II was 99.0% as compared to 99.5% for the reference tests.

Consequently, Visuwell® Reagin II is substantially equivalent to reference tests in predictive value of positive for STD populations and predictive value of negative.

Cross-Reactivity

Cross-Reactivity results were obtained from 151 specimens consisting of specimens from individuals with a variety of bacterial, viral and auto-immune disorders. Specimens identified as syphilis biological false-positives and specimens from conditions frequently associated with false reactivity in nontreponemal screen tests such as pregnancy and drug abuse were included in these results.

PAGE 4 OF 5

4

Image /page/4/Picture/0 description: The image shows the logo for "BIOMIRA DIAGNOSTICS INC.". The word "BIOMIRA" is in large, bold, white letters against a black background. Below that, "DIAGNOSTICS INC." is in smaller, black letters against a white background.

The specificity of Visuwell® Reagin II in the clinical population characterized by non-syphilitic diseases or conditions was 86.8% as compared to 91.9% with the reference tests. These results indicate that the performance of Visuwell® Reagin II is substantially equivalent to the reference tests for specimens that have potential for interference.

Overall Agreement

The overall agreement between the Visuwell® Reagin II and the reference tests results for all sera (11,443 specimens) was 96.5%. Visuwell® Reagin II is substantially equivalent to non-treponemal reference tests in overall agreement of test results.

Conclusion

ﻟﺴﻬﻤﻪ، ﻧ

The safety and effectiveness of Visuwell® Reagin II is substantially equivalent to legally marketed non-treponemal reference tests (VDRL, RPR, RST) as demonstrated in the comparison of the performance of Visuwell® Reagin to these tests.

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