RUBASCAN CARD TEST

K952721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · LFX · Dec 20, 1996 · Microbiology

Device Facts

• Record ID: K952721
• Device Name: RUBASCAN CARD TEST
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: LFX · Microbiology
• Decision Date: Dec 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Indications for Use

The RUBAscan® Card Test is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies in human serum. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The choice of protocol used may be based upon judgments concerning the significance of immune status given by antibody levels in protecting the individual from primary rubella infection. The RUBAscan® Card Test can also be used to give quantitative results when used to test serial dilutions of the specimen. With properly selected paired specimens, the test can determine recent or active infection.

Device Story

Passive latex agglutination test; detects rubella antibodies in human serum. Input: human serum specimen (undiluted or serial dilutions). Principle: latex particles sensitized with solubilized rubella virus antigens; mixed with serum on card surface. Output: visual agglutination (clumps) indicates presence of antibodies; smooth/dispersed latex indicates absence or insufficient concentration. Used in clinical laboratory settings by trained personnel. Provides qualitative immune status or quantitative antibody levels. Aids clinicians in determining patient immunity to rubella or identifying active infection.

Clinical Evidence

Internal and external clinical studies validated 1:10 dilution equivalence to 10 IU/mL cut-off. Compared against commercial EIA reference; nonconcordant results resolved via commercial latex assay. Met ≥95% sensitivity/specificity criteria. CDC evaluation panel (n=100) showed 100% correct identification. Reproducibility studies confirmed acceptable performance at 10 IU/mL cut-off.

Technological Characteristics

Passive latex agglutination assay. Reagent: latex particles sensitized with solubilized rubella virus antigens from disrupted virions. Manual card-based test format. No electronic components, software, or external energy source required.

Indications for Use

Indicated for detection and/or quantitation of rubella antibodies in human serum to assess immune status or determine recent/active infection.

Regulatory Classification

Identification

Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

Predicate Devices

• RUBAscan® Card Test (K832228)

Submission Summary (Full Text)

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K952721
June 14, 1995

# SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY:
*DEC 20 1996*

Judith J. Smith
Becton Dickinson Microbiology Systems
P O Box 243
Cockeysville, MD 21030-0243

## NAME OF DEVICE:

| Trade Name: | RUBAscan® Card Test |
| --- | --- |
| Common Name/Description: | Latex agglutination for Rubella antibodies |
| Classification Name: | Latex agglutination assay, Rubella |

## PREDICATE DEVICE:

K832228; RUBAscan® Card Test

## DEVICE DESCRIPTION:

**INTENDED USE:** The RUBAscan® Card Test is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies in human serum. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The choice of protocol used may be based upon judgments concerning the significance of immune status given by antibody levels in protecting the individual from primary rubella infection.

The RUBAscan® Card Test can also be used to give quantitative results when used to test serial dilutions of the specimen. With properly selected paired specimens, the test can determine recent or active infection.

**KIT DESCRIPTION:** The RUBAscan® Card Test is based upon the well established principles of passive latex agglutination. Latex is sensitized according to a patented process using solubilized rubella virus antigens from disrupted virions. This latex reagent, when mixed with serum containing rubella antibodies on a card surface, will agglutinate, forming visible clumps. In the absence of antibody, or if the concentration is insufficient to react, the latex will remain smooth and evenly dispersed.

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A single specimen can be used to obtain a qualitative judgment about its antibody content. Analysis of dilutions of the specimen can give quantitative results.

## PERFORMANCE DATA:

**Clinical Correlation:** The following studies were conducted to enable the addition of a quantitative sensitivity claim of 10 IU/mL at the 1:10 screening dilution. The NCCLS guideline I/LA6-T was used as a guideline for performing the testing.

- Internal testing was conducted to validate that the RUBAscan® Card Test dilution of 1:10 is equivalent to the 10 IU/mL cut-off.

**Conclusion:** The RUBAscan® Card Test met the acceptance criteria (≥ 95% as suggested by the NCCLS guidelines) for sensitivity and specificity of the in-house testing at the dilution of 1:10 when a commercially available EIA was used as the reference and a commercially available latex assay was used to resolve nonconcordant results.

- Two external studies were conducted to validate that the screening dilution of the RUBAscan® Card Test in clinical laboratories' hands was equivalent to the 10 IU/mL immune status cut-off as defined by the commercially available EIA.

**Conclusion:** The RUBAscan® Card Test resolved sensitivity and specificity met the 95% confidence intervals for the observed sensitivity and specificity including 95% at the two sites.

- A CDC evaluation panel was tested internally using a 1:10 dilution.

**Conclusion:** The RUBAscan® Card Test identified all 100 samples correctly.

## Reproducibility:

- Two external studies were conducted to validate dilution reproducibility at the 10 IU/mL cut-off.

**Conclusion:** Reproducibility of the RUBAscan® Card Test was acceptable.

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