VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS

K063143 · Ortho-Clinical Diagnostics, Inc. · LFX · Dec 26, 2006 · Microbiology

Device Facts

• Record ID: K063143
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Dec 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System. The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.

Device Story

VITROS Rubella IgG assay is an automated immunometric assay for human serum/plasma; utilizes rubella antigen-coated wells to capture anti-rubella IgG; employs mouse monoclonal anti-human IgG HRP-labeled conjugate; bound HRP measured via luminescent reaction using luminogenic substrates and electron transfer agent; light signal intensity proportional to anti-rubella IgG concentration; performed on VITROS Immunodiagnostic System; used by clinical laboratory personnel to assess rubella immunity status; aids clinical decision-making regarding patient immune status.

Clinical Evidence

Clinical performance evaluated in two studies. Study 1: 871 prospective samples (Europe); positive agreement 98.6%, negative agreement 91.1% (excluding equivocals). Study 2: 592 retrospective samples (US); positive agreement 97.5%, negative agreement 98.3% (excluding equivocals). Comparison against Abbott AxSYM predicate. Clinical cut-off established at 10 IU/mL per NCCLS I/L6-A.

Technological Characteristics

Solid-phase immunometric assay; enzyme-labeled (HRP) detection; luminescent signal generation; automated system; sample volume 10μL; incubation 35 minutes at 37°C; utilizes mouse monoclonal anti-human IgG; compliant with CLSI standards I/LA6, EP5, EP6, EP7, EP9.

Indications for Use

Indicated for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma to aid in the determination of immune status to rubella virus infection in clinical laboratory settings.

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 AXSYM Rubella IgG Assay (K954045)

Submission Summary (Full Text)

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#### 510(k) SUMMARY INFORMATION 2.0

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# 1.1 Name, Address of Applicant and Contact Person

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 [phone]

DEC 26 2006

Contact Person: Charlotte Baker

#### 1.2 Preparation Date

October 13, 2006

#### 1.3 Device Trade or Proprietary Name

VITROS Immunodiagnostic Products Rubella IgG Reagent Pack VITROS Immunodiagnostic Products Rubella IgG Calibrators

Common Name: Rubella IgG Assay

#### 1.4 Classification (Generic) Name of Device

Immunoassay Method, Rubella IgG Method Regulation 866.3510 Class: 2 Product Code: LFX

#### 1.5 Predicate Device

ABBOTT AxSYM Rubella IgG Assay: K954045.

#### 1.6 Device Description

The VITROS Rubella IgG assay is performed using the VITROS Immunodiagnostic Products Rubella IgG Reagent Pack and VITROS Immunodiagnostic Products Rubella IgG Calibrators on the VITROS Immunodiagnostic System for the qualitative and quantitative determination of rubella IgG antibodies to rubella virus in human serum and plasma. An immunometric technique is used. This involves the reaction of antirubella IgG present in the sample with rubella antigen coated onto the wells. After a wash step a horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal anti-human IgG) is added and this complexes with bound anti-rubella IgG. Unbound materials are removed by washing.

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The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the VITROS Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the concentration of antirubella IgG present.

### 1.7 Device Intended Use

For in vitro diagnostic use only.

The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System.

The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.

#### 1.8 Comparison to Predicate Device

The VITROS Rubella IgG Reagent Pack and Calibrators are substantially equivalent to the ABBOTT AxSYM Rubella IgG Assay (predicate device) which was cleared by the FDA (K954045) for IVD use.

Table 1 (next page) presents the similarities and differences of both assays.

Ortho-Clinical Diagnostics, Inc.

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| Similarities | | |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | New Device-VITROS Rubella IgG<br>assay | Predicate Device-ABBOTT<br>AxSYM Rubella IgG assay |
| Intended Use | For <i>in vitro</i> diagnostic use only.<br>The VITROS Immunodiagnostic<br>Products Rubella IgG assay is<br>intended for the quantitative<br>determination of IgG antibodies to<br>rubella virus in human serum and<br>plasma (heparin, EDTA or sodium<br>citrate) using the VITROS<br>Immunodiagnostic System.<br><br>The VITROS Rubella IgG assay is for<br>use in the clinical laboratory as an aid<br>in the determination of immunity to<br>rubella virus infection. | The AxSym Rubella IgG assay is a<br>Microparticle Enzyme Immunoassay<br>(MIA) for the qualitative and<br>quantitative measurement of IgG<br>antibodies to rubella virus in serum<br>or plasma (EDTA, heparin or sodium<br>citrate) to aid in the determination of<br>immune status to rubella. |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | Automated Immunoassay System | Automated Immunoassay System |
| Sample type | Serum and plasma (EDTA, heparin, or<br>sodium citrate) | Serum and plasma (EDTA, heparin,<br>or sodium citrate) |
| Antigen virus strain | HPV-77 | HPV-77 |
| Calibrator format | Liquid | Liquid |
| Linearity with W.H.O. 1st<br>International standard-<br>Assay range | r = 0.999 | r = 0.9999 |
| Linearity with W.H.O. 1st<br>International standard from<br>0-20 IU/mL | r = 0.9988 | Unknown |
| CDC Panel evaluation | Yes | Yes |
| Positive % Agreement/<br>Initial Sensitivity | Study 1: 98.6%<br>Study 2: 97.5% | 99.5% |
| Negative % Agreement/<br>Initial Specificity | Study 1: 91.1%<br>Study 2: 98.3% | 90.8% |
| Calibrators referenced to<br>W.H.O. | Yes | Yes |
| CLSI Standards Used | I/LA6, EP5, EP6, EP7, EP9 | I/LA6, EP5 |
| Differences | | |
| Antibody | Mouse monoclonal anti-human IgG | Goat anti-Human IgG |
| Sample volume | 10μL | 180μL |
| Calibrator levels | 3 | 6 |
| Reportable range | 0-350 IU/mL | 0-500 IU/mL |
| Incubation time and<br>temperature | 35 minutes at 37°C | 20 minutes at 37°C |

# Table 1 Assay Characteristics

Ortho-Clinical Diagnostics, Inc.

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# 1.9 Conclusions

The data presented in the premarket notification provide a reasonable assurance that the VITROS Rubella IgG Assay is safe and effective for the stated intended use and is substantially equivalent to the cleared predicate device.

Ortho-Clinical Diagnostics, Inc.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ortho-Clinical Diagnostics, Inc. c/o Charlotte Baker 100 Indigo Creek Dr. Rochester, NY 14626

# DEC 26 2006

Re: k063143

Trade/Device Name: VITROS Immunodiagnostic Products Rubella IgG Reagent Pack VITROS Immunodiagnostic Products Rubella IgG Calibrators Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella virus serological reagents Regulatory Class: Class II Product Code: LFX Dated: December 13, 2006 Received: December 14, 2006

Dear Ms. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product rained on one of begin marketing your device as described in your Section 510(k) I mo letter with a month and finding of substantial equivalence of your device to a legally promaticated predicated 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), please in you attire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general starters, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Salyat
Sally A. Haiyat

Sally A. Hojvat Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INTENDED USE 1.0 KOG3143

510(k) Number (if known):

Device Name:

VITROS Rubella IgG Reagent Pack VITROS Rubella IgG Calibrators

Indications for Use:

VITROS Rubella IgG Assay

For in vitro diagnostic use only.

The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System.

The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Noy an
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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KO 6 314 3 510(k)

Ortho-Clinical Diagnostics, Inc.

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