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 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. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VITROS Rubella IgG Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a numerical target format (e.g., "Sensitivity must be >95%"). Instead, it compares the performance of the new device to a predicate device. The "acceptance" is implied by demonstrating substantial equivalence to the predicate device.

Performance Metric	Predicate Device (ABBOTT AxSYM Rubella IgG Assay)	New Device (VITROS Rubella IgG Assay) - Study 1	New Device (VITROS Rubella IgG Assay) - Study 2
Positive % Agreement / Initial Sensitivity	99.5%	98.6%	97.5%
Negative % Agreement / Initial Specificity	90.8%	91.1%	98.3%
Linearity with W.H.O. 1st International standard - Assay range	r = 0.9999	r = 0.999	Not applicable (single study for this metric)
Linearity with W.H.O. 1st International standard from 0-20 IU/mL	Unknown	r = 0.9988	Not applicable (single study for this metric)
CDC Panel evaluation	Yes	Yes	Not applicable (single study for this metric)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the test sets (i.e., the number of samples used to determine Positive % Agreement and Negative % Agreement). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information about the number of experts, their qualifications, or how they established the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is an in-vitro diagnostic device (IVD) for laboratory use and does not involve human readers interpreting results. Inter-rater variability studies are more applicable to imaging or subjective interpretations rather than quantitative immunoassay results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is implicitly a standalone performance study. The "device performance" refers to the output of the VITROS Immunodiagnostic System itself, without a human in the loop for interpretation beyond running the assay and reading the quantitative results. The output of the device is a quantitative determination of IgG antibodies, which is then used by laboratory personnel to aid in determining immunity.

7. The Type of Ground Truth Used

The document does not explicitly state the specific type of "ground truth" used for the studies that generated the Positive % Agreement and Negative % Agreement. However, given that it's an immunoassay for rubella IgG, the ground truth would typically be established by:

Reference Methods: Highly sensitive and specific laboratory reference assays for rubella IgG antibodies.
Clinical Status: Correlation with confirmed rubella infection history or vaccination status for clinical immunity determination.
CDC Panel Evaluation: The mention of "CDC Panel evaluation" indicates that standardized panels from the Centers for Disease Control and Prevention were likely used, which represent well-characterized samples with established rubella IgG status.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for a training set. This is typical for in-vitro diagnostic assays, where a "training set" in the context of machine learning isn't usually a separate, explicitly defined component in the same way it would be for a typical AI/ML medical device. Instead, the assay's design, calibration, and optimization (which can be considered analogous to "training") are performed using a range of characterized samples during the development phase.

9. How the Ground Truth for the Training Set Was Established

Since an explicit "training set" as understood in AI/ML is not described, the method for establishing its "ground truth" is also not detailed. However, for the development and optimization of such an immunoassay, the manufacturer would use precisely characterized samples with known concentrations or presence/absence of rubella IgG antibodies, likely derived from reference materials, clinical samples with confirmed status, and potentially fortified samples.

Summary

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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 (585) 453-3730

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

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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 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
DeviceCharacteristic	New Device-VITROS Rubella IgGassay	Predicate Device-ABBOTTAxSYM Rubella IgG assay
Intended Use	For in vitro diagnostic use only.The VITROS ImmunodiagnosticProducts Rubella IgG assay isintended for the quantitativedetermination of IgG antibodies torubella virus in human serum andplasma (heparin, EDTA or sodiumcitrate) using the VITROSImmunodiagnostic System.The VITROS Rubella IgG assay is foruse in the clinical laboratory as an aidin the determination of immunity torubella virus infection.	The AxSym Rubella IgG assay is aMicroparticle Enzyme Immunoassay(MIA) for the qualitative andquantitative measurement of IgGantibodies to rubella virus in serumor plasma (EDTA, heparin or sodiumcitrate) to aid in the determination ofimmune 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, orsodium citrate)	Serum and plasma (EDTA, heparin,or sodium citrate)
Antigen virus strain	HPV-77	HPV-77
Calibrator format	Liquid	Liquid
Linearity with W.H.O. 1stInternational standard-Assay range	r = 0.999	r = 0.9999
Linearity with W.H.O. 1stInternational standard from0-20 IU/mL	r = 0.9988	Unknown
CDC Panel evaluation	Yes	Yes
Positive % Agreement/Initial Sensitivity	Study 1: 98.6%Study 2: 97.5%	99.5%
Negative % Agreement/Initial Specificity	Study 1: 91.1%Study 2: 98.3%	90.8%
Calibrators referenced toW.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 andtemperature	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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Page 2 -

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 (240) 276-0443. 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 (800) 638-2041 or (240) 276-3150 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 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

Page 1 of 1

KO 6 314 3 510(k)

Ortho-Clinical Diagnostics, Inc.

Page 6 of 166

Regulation Number and Section

§ 866.3510 Rubella virus serological reagents.

(a)
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).(b)
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.