COPALIS RUBELLA IGM

K993291 · DiaSorin, Inc. · LFX · Feb 10, 2000 · Microbiology

Device Facts

• Record ID: K993291
• Device Name: COPALIS RUBELLA IGM
• Applicant: DiaSorin, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Feb 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Copalis® Rubella IgM assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle aggregation-based immunoassay for the qualitative detection of IgM antibodies to rubella virus in human serum and EDTA, heparin or sodium citrate plasma using the Copalis® I Immunoassay System. The test is indicated for the presumptive diagnosis of primary rubella infection.

Device Story

Device uses Coupled Particle Light Scattering (Copalis) technology for qualitative detection of IgM antibodies to Rubella virus. Input: human serum or plasma (EDTA, heparin, sodium citrate). Process: sample manually pre-diluted to remove IgG/IgA; mixed with polystyrene microparticles coated with Rubella viral antigen (HPV 77 strain). Presence of IgM antibodies causes particle aggregation. System measures light scattering changes as particles flow past detector after 10-minute agitation. Output: reactivity level relative to cutoff value. Used in clinical laboratory settings; operated by trained laboratory personnel. Results assist clinicians in diagnosing primary rubella infection.

Clinical Evidence

Clinical trials conducted at 3 sites compared Copalis Rubella IgM to Abbott IMx Rubella IgM. Total of 114 samples (acute adult), 50 (obstetric), 99 (seronegative), and 20 (pediatric). Agreement rates: 98.2% (acute), 100% (obstetric), 100% (seronegative), and 100% (pediatric). Reproducibility studies performed using 6-member panels tested in duplicate over 5 days; within-run %CV ranged from 1.4% to 12.3%.

Technological Characteristics

Uses Coupled Particle Light Scattering (Copalis) technology. Reagents include polystyrene microparticles coated with Rubella viral antigen (HPV 77 strain). Operates on the Copalis I Immunoassay System. Qualitative detection based on antibody-dependent particle aggregation measured by light scattering changes. Sample types: serum, EDTA plasma, heparin plasma, sodium citrate plasma.

Indications for Use

Indicated for the presumptive diagnosis of primary rubella infection in human serum and EDTA, heparin, or sodium citrate plasma.

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

• Abbott Laboratories IMx Rubella IgM (MEIA)

Submission Summary (Full Text)

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FFB 1 0 2000

K993291

January 8, 2000

## 510(k) Summarv

SUBMITTED BY:

Judith J. Smith DiaSorin, Inc. 9175 Guilford Rd. Suite 100 Columbia, MD 21046

NAME OF DEVICES: Trade Name:

Copalis® Rubella IgM Assay

Common Names/Descriptions:

Immunoassay for the Detection of IgM Antibodies to Rubella virus

Classification Names:

Rubella Serology Test

PREDICATE DEVICES:

Abbott Laboratories IMx Rubella IgM (MEIA)

DEVICE DESCRIPTION: INTENDED USE:

The Copalis® Rubella IgM assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle aggregation-based immunoassay for the qualitative detection of IgM antibodies to Rubella virus in human serum and EDTA, heparin or sodium citrate plasma using the Copalis® I Immunoassay System. The test is indicated for the presumptive diagnosis of primary rubella infection.

KIT DESCRIPTION: Coupled Particle Light Scattering (Copalis®) technology Coupled Particle Light Scattering (Copalis®) technology provides a rapid method for the measurement of antibodies to specific viral or protozoan pathogens.

The Copalis® Rubella IgM Assay is based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. The serum or plasma sample is manually pre-diluted in Sample Diluent to remove IgG and IdA antibodies. Polystyrene microparticles present in the Copalis® Test Cup are coated with Rubella viral antigen (HPV 77 strain). These microparticles aggregate in the presence of the pre-diluted human serum/plasma containing IgM antibodies to Rubella virus. After 10 minutes of agitation, the levels of aggregation are determined by measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation relative to a cutoff value. The Copalis® Rubella IgM Assay detects the presence of Rubella IgM-specific antibodies. Two levels of controls are used to monitor system performance.

#### PERFORMANCE DATA:

Clinical Correlation: Clinical trials were conducted at 3 sites (1 hospital clinical laboratory, 1 state laboratory and at DiaSorin) to evaluate the performance of the Copalis® Rubella IgM Assay in detecting IgM antibodies to Rubella antigen on the Copalis® I Immunoassay System. The assay performance was compared to the Abbott IMx Rubella IgM test.

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| | Copalis Rubella IgM | | | |
|-----------------|---------------------|-----|----|-------------|
| IMx Rubella IgM | Pos | Neg | EQ | Grand Total |
| Pos | 70 | 1 | 0 | 71 |
| Neg | 1 | 38 | 0 | 39 |
| EQ | 1 | 3 | 0 | 4 |
| Grand Total | 72 | 42 | 0 | 114 |

#### Summary of Acute Adult Population for Copalis® Rubella IgM Assay

Agreement [95% CI]

98.2% (108/110) [93.6 - 99.8%]

## Summary of Obstetric Adult Population for Copalis® Rubella IgM Assay

| | Copalis Rubella IgM | | | |
|-----------------|---------------------|-----|----|-------------|
| IMx Rubella IgM | Pos | Neg | EQ | Grand Total |
| Pos | 0 | 0 | 0 | 0 |
| Neg | 0 | 50 | 0 | 50 |
| EQ | 0 | 0 | 0 | 0 |
| Grand Total | 0 | 50 | 0 | 50 |

Agreement [95% CI]

100.0% (50/50) [92.9 - 100.0%]

## Summary of Seronegative Population for Copalis® Rubella IgM Assay

| | Copalis Rubella IgM | | | |
|-----------------|---------------------|-----|----|-------------|
| IMx Rubella IgM | Pos | Neg | EQ | Grand Total |
| Pos | 0 | 0 | 0 | 0 |
| Neg | 0 | 97 | 1 | 98 |
| EQ | 0 | 1 | 0 | 1 |
| Grand Total | 0 | 98 | 1 | 99 |

Agreement [95% CI]

100.0% (97/97) [96.3 — 100.0%]

#### Summary of Pediatric Population for Copalis® Rubella IgM Assay

| | Copalis Rubella IgM | | | |
|-----------------|---------------------|-----|----|-------------|
| IMx Rubella IgM | Pos | Neg | EQ | Grand Total |
| Pos | 3 | 0 | 0 | 3 |
| Neg | 0 | 17 | 0 | 17 |
| EQ | 0 | 0 | 0 | 0 |
| Grand Total | 3 | 17 | 0 | 20 |

Agreement [95% CI]

100.0% (20/20) [83.2 - 100.0%]

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Reproducibility: Reproducibility studies were performed at three sites using one lot of Copalis® Rubella IgM reagents. Assay reproducibility was determined by assaying a reproducibility panel consisting of six serum samples that covered the range of the Copalis® Rubella IgM assay. Panel members were tested in duplicate once a day for five days. Results expressed in Copalis Test Results (CTR) are summarized by combined site results.

| Copalis CTR | | | |
|-------------|------|-------|-------------------|
| Sample ID | Mean | %CV | Within Run<br>%CV |
| Neg Control | 100 | 1.7% | na |
| Pos Control | 136 | 8.0% | na |
| NRM01-01 | 102 | 3.0% | 2.2% |
| NRM01-02 | 102 | 2.7% | 1.4% |
| PRM01-01 | 156 | 12.4% | 8.9% |
| PRM01-02 | 142 | 9.8% | 6.9% |
| PRM01-03 | 117 | 5.1% | 3.8% |
| PRM01-04 | 364 | 18.5% | 12.3% |
| Sample N | 30 | 30 | 30 |

## Copalis CTR Results Sites Combined - Copalis Rubella IgM Assay

Plasma reproducibility studies were performed at DiaSorin using one lot of Copalis® Rubella IgM. Six sets of serum/ multiple plasma paired samples were prepared using EDTA. heparin and sodium citrate plasma and spanned the range of the assay. The samples were tested in duplicate once a day for 3 days.

| CTR | serum | | | EDTA plasma | | | HEPARIN plasma | | | CITRATE plasma | | |
|-----|-------|------------|------|-------------|------------|------|----------------|------------|------|----------------|------------|------|
| | total | within run | | total | within run | | total | within run | | total | within run | |
| | mean | %CV | %CV | mean | %CV | %CV | mean | %CV | %CV | mean | %CV | %CV |
| N1 | 102 | 2.57 | 1.37 | 102 | 2.43 | 1.37 | 106 | 1.48 | 0.67 | 102 | 1.20 | 0.35 |
| N2 | 100 | 2.36 | 1.41 | 105 | 2.25 | 1.02 | 100 | 2.16 | 1.07 | 92 | 31.54 | 1.39 |
| HP | 200 | 6.23 | 3.54 | 196 | 8.01 | 4.41 | 176 | 5.71 | 2.39 | 191 | 10.07 | 2.53 |
| LP1 | 130 | 4.32 | 1.66 | 131 | 5.13 | 1.39 | 125 | 2.90 | 1.17 | 124 | 3.49 | 0.57 |
| LP2 | 139 | 4.90 | 1.31 | 144 | 5.73 | 3.28 | 145 | 4.10 | 1.94 | 143 | 3.92 | 1.22 |

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its wings and body. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

# FEB 1 0 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Judith J. Smith Process Owner, Worldwide Regulatory Affairs and Quality System DiaSorin, Inc. 9175 Guilford Road, Suite 100 Columbia, Maryland 21046

Re: K993291 Trade Name: Copalis® Rubella IgM Assay Regulatory Class: III Product Code: LFX Dated: December 13, 1999 Received: December 14, 1999

Dear Ms. Smith:

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 legally marketed predicate 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, Drug, 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, labeling, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/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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# INDICATIONS FOR USE

510(k) Number (if known): K993291

Copalis® Rubella IgM Assay Device Name:

Indications For Use: The Copalis® Rubella IgM assay uses Coupled Particle Light Scattering (Copalis®) technology in a microparticle aggregation-based immunoassay for the qualitative detection of IgM antibodies to rubella virus in human serum and EDTA, heparin or sodium citrate plasma using the Copalis® I Immunoassay System. The test is indicated for the presumptive diagnosis of primary rubella infection.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Duboe

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993291

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)