RUBELLACOL

K031490 · Immunostics Inc., · LQN · Jul 16, 2003 · Microbiology

Device Facts

• Record ID: K031490
• Device Name: RUBELLACOL
• Applicant: Immunostics Inc.,
• Product Code: LQN · Microbiology
• Decision Date: Jul 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Indications for Use

The RUBELLACOL™ TEST is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For Professional Use Only".

Device Story

Rubellacol is a color-enhanced latex agglutination slide test for detecting rubella virus antibodies in human serum. The device utilizes polystyrene latex particles coated with purified K2S antigen extract from Rubella HPV-77 virus (grown in African Green Monkey Kidney Vero cells). The suspension buffer contains compatible dyes to facilitate visual observation of the antigen-antibody reaction. The test is performed manually by professional laboratory personnel. The presence of agglutination indicates a positive result, while the absence indicates a negative result. The test provides qualitative and semi-quantitative results to assist clinicians in assessing patient immune status or identifying recent/active infection. It is not intended for prenatal or newborn screening.

Clinical Evidence

Performance validated through three retrospective/prospective comparison studies and a CDC panel. Study 1 (n=545) showed 98.5% total agreement. Study 2 (n=200) showed 99% total agreement. Study 3 (n=200) showed 98% total agreement. CDC panel (n=50) demonstrated 100% agreement with positive and negative specimens. Analytical performance includes >92% reproducibility and no prozone effect up to 1600 IU/ml. Assay cut-off is 10 IU/ml.

Technological Characteristics

Latex particle agglutination assay. Reagent consists of deeply colored polystyrene latex particles coated with purified K2S antigen extract from Rubella HPV-77 virus (Vero cell line). Employs color-enhanced visual observation of antigen-antibody reaction. Manual slide-based test format. Traceable to WHO standards.

Indications for Use

Indicated for the detection of anti-rubella virus antibodies in serum to aid in the diagnosis of recent or active rubella infection and determination of immune status. For professional use only.

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.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
k031490

B. Analyte:
Rubella antibodies

C. Type of Test:
Latex particle agglutination test

D. Applicant:
Immunostics, Inc.

E. Proprietary and Established Names:
Rubellacol

F. Regulatory Information:
1. Regulation section:
21 CFR 866.3510, Rubella Virus, Serological Reagents
2. Classification:
Class II
3. Product Code:
LQN, Latex Agglutination Assay, Rubella
4. Panel:
Microbiology (83)

G. Intended Use:
1. Intended use(s):
Rubellacol is a color enhanced rapid latex agglutination slide test for the qualitative and semi-quantitative detection of rubella virus antibodies in serum. Rubellacol slide test is a rapid latex particle agglutination test aiding in the diagnosis of recent or active rubella infection and the determination of immune status. The assay's performance characteristics have not been established for prenatal or newborn testing.
2. Indication(s) for use:
The Rubellacol test is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For professional Use Only."
3. Special condition for use statement(s):
4. Special instrument Requirements:

H. Device Description:
The Rubellacol reagent is a suspension of deeply colored polystyrene latex particles of uniform size coated with a soluble purified K2S antigen extract prepared from Rubella HPV-77 virus grown in African Green Monkey Kidney Vero cell line.

I. Substantial Equivalence Information:
1. Predicate device name(s):

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Wampole Impact Rubella Slide Test

2. Predicate K number(s):
k844435

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| 1. Material | Polystyrene latex particles | Polystyrene latex particles |
| 2. antigen | Disrupted virus | Disrupted virus |
| 3. procedure | Qualitative and semiquantitative | Qualitative and semiquantitative |
| Differences | | |
| Item | Device | Predicate |
| 1. Material | Color change latex particles | White latex particles |
| 2. dilution | Initial serum dilution at 1:10 | Initial serum dilution at 1:8 |

J. Standard/Guidance Document Referenced (if applicable):

K. Test Principle:
The latex particles are matched with compatible dyes in the suspension buffer which results in a color-enhanced visual observation of the antigen-antibody reaction.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Reproducibility of the end point is greater than 92%.
b. Linearity/assay reportable range:
No prozone effect up to 1600 IU/ml.
c. Traceability (controls, calibrators, or method):
WHO Standard
d. Detection limit:
e. Analytical specificity:
No cross reactivity study was performed. A limitation is placed stating that the users should establish their own cross reactivity data.
f. Assay cut-off:
10 IU/ml

2. Comparison studies:
a. Method comparison with predicate device:

Study #1:
A comparison study was conducted at Immunostics Inc. comparing 545 human serum specimens containing known Rubella positive, borderline and negative samples retrospectively collected. The demographic and geographic distribution was not

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specified but were collected from donor centers around the USA. These samples were assayed employing the Rubellacol slide test and a commercially available latex agglutination test.

Positive Agreement: 99.4% (471/474)
Negative Agreement: 93% (66/71)
Positive Agreement: 98.5% (537/545)

**Study #2:**
A second comparison study was conducted at a private research and product development facility in Mid-Atlantic region of the United States. 200 human serum specimens containing known Rubella positive, borderline and negative samples retrospectively collected were tested. The demographic and geographic distribution was not specified but were collected from donor centers around the USA. These samples were assayed employing the Rubellacol slide test and a commercially available latex agglutination test.

Positive Agreement: 100% (187/187)
Negative Agreement: 84.6% (11/13)
Total Agreement: 99% (198/200)

**Study #3:**
A third comparison study was conducted at a large metropolitan hospital in New England comparing 200 human serum specimens containing unknown Rubella titers. The samples were prospectively collected from the hospital's research sample bank. The demographic distribution was not specified but the samples were from hospital patients from the New England area. These samples were assayed employing the Rubellacol slide test and a commercially available latex agglutination (LA) test.

Positive Agreement: 99.4% (178/179)
Negative Agreement: 85.7% (18/21)
Total Agreement: 98% (196/200)

**CDC Panel**
The panel (50 specimens in duplicate) consisted of 82% positive and 18% negative samples. The Rubellacol test demonstrated 100% agreement with the positive specimens and 100% agreement with negative specimens.

b. Matrix comparison:

3. Clinical studies:
a. Clinical sensitivity:
b. Clinical specificity:

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c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:

5. Expected values/Reference range:

**M. Conclusion:**

The Performance characteristics reported here for the device indicate that it is comparable to the other such test kits currently in the market.