VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

K030067 · Ortho-Clinical Diagnostics · MJX · Jan 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030067
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: MJX · Clinical Chemistry
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate and heparin). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays. For in vitro diagnostic use.

Device Story

Vitros Immunodiagnostic Products HBsAg Controls are quality control materials used to monitor the performance of the Vitros ECi Immunodiagnostic System. The system performs qualitative detection of HBsAg in human serum and plasma using luminescence-based immunoassay technology. The controls consist of positive and negative levels derived from human serum with added constituents and antimicrobial agents. They are used by laboratory personnel to verify assay performance across different sample matrices (serum, EDTA, citrate, heparin). The system utilizes coated microwells for solid-phase separation and automated instrumentation to process reagent packs and calibrators. By comparing control results against lot-specific quoted mean values and standard deviations, clinicians ensure the reliability of patient HBsAg test results, supporting accurate diagnostic decision-making for Hepatitis B.

Clinical Evidence

Bench testing only. Technical report evaluated multiple samples collected as whole serum or in the presence of EDTA, citrate, or heparin. Samples were tested either unspiked (negative) or spiked with known positive HBsAg plasma near the assay's weak positive detection limit. Results confirmed that all sample matrices behave similarly in the assay, supporting the use of controls for monitoring performance across serum and plasma.

Technological Characteristics

Quality control material consisting of human serum, added human-origin constituents, and antimicrobial agents. Used with Vitros ECi Immunodiagnostic System (luminescence-based immunoassay). Controls provide lot-specific mean values and standard deviations derived from a minimum of 10 assays across multiple laboratories.

Indications for Use

Indicated for monitoring the performance of the Vitros ECi Immunodiagnostic System during in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate, heparin).

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Vitros Immunodiagnostic Products HBsAg Controls (K011250)

Reference Devices

• Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator (PMA P000044)
• Vitros Immunodiagnostic System (K962919)
• Vitros Immunodiagnostic Products Total T3 (K964310)

Submission Summary (Full Text)

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K030067

# General Information 2.0

# JAN 1 7 2003

Confidential and Proprietary

#### 510(k) Summary 2.1

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.

The assigned 510(k) number is: ______________

#### Submitter Name, Address, Contact 2.1.1

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

Contact Person: Sarah Parsons

#### 2.1.2 Preparation Date

Date 510(k) Summary Prepared:

#### 2.1.3 Device Name

Trade or Proprietary Name: Vitros Immunodiagnostic Products HBsAg Controls

HBsAg Controls Common Name:

Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed).

#### 2.1.4 Predicate Device

The Vitros Immunodiagnostic Products HBsAg Controls are substantially equivalent to Ortho-Clinical Diagnostics, Inc. Vitros Immunodiagnostic Products HBsAg Controls (K011250).

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#### Device Description 2.1.5

The Vitros Immunodiagnostic System uses luminescence as the signal in the qualitative detection of HBsAg in human plasma and serum. Coated microwells are used as the solid phase separation system.

The system is compromised of three main elements:

- The Vitros Immunodiagnostic Products range of products, in this case 1. Vitros Immunodiagnostic Products HBsAg Reagent Pack and Vitros Immunodiagnostic Products Calibrator, which are combined by the Vitros Immunodiagnostic System to perform a Vitros assay. The Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator have been approved for sale (PMA P000044).
- The Vitros Immunodiagnostic System- instrumentation, which provides 2. automated use of the immunoassay kits. The Vitros Immunodiagnostic System was cleared be market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the Vitros System in each assay. The Vitros 3. Immunodiagnostic Products Signal Reagent and the Vitros Immunodiagnostic Products Universal Wash Reagent were cleared as part of the Vitros Immunodiagnostic Products Total T3 510(k) premarket notification (K964310).

The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.

### Device Intended Use 2.1.6

The Vitros Immunodiagnostic Products HBsAg Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, heparin or citrate). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays.

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# Comparison to Predicate Device 2.1.7

The Vitros Immunodiagnostic Products HBsAg Controls are substantially equivalent to Ortho-Clinical Diagnostics Inc. Vitros Immunodiagnostic Products HBsAg Controls (K011250)

Table 1 lists the characteristics of the Vitros Immunodiagnostic Products HBsAg Controls (new device) and the Vitros Immunodiagnostic Products HBsAg Controls (predicate device).

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| Device<br>Characteristic | Vitros<br>Immunodiagnostic<br>Products HBsAg<br>Controls<br>(New device) | Vitros<br>Immunodiagnostic<br>Products HBsAg<br>Controls<br>(Predicate device) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in monitoring the<br>performance of the Vitros<br>ECi Immunodiagnostic<br>System when used for the<br>in vitro qualitative<br>detection of Hepatitis B<br>Surface Antigen (HBsAg)<br>in human serum and<br>plasma (EDTA, citrate<br>and heparin). The<br>performance of the Vitros<br>Immunodiagnostic<br>Products HBsAg Controls<br>has not been established<br>with any other HBsAg<br>assays. | For use in monitoring the<br>performance of the Vitros<br>ECi Immunodiagnostic<br>System when used for the<br>in vitro qualitative<br>detection of Hepatitis B<br>Surface Antigen (HBsAg)<br>in human serum. The<br>performance of the Vitros<br>Immunodiagnostic<br>Products HBsAg Controls<br>has not been established<br>with any other HBsAg<br>assays. |
| Matrix of controls | Human serum with added<br>constituents of human<br>origin and antimicrobial<br>agents | Human serum with added<br>constituents of human<br>origin and antimicrobial<br>agents |
| Control level | Positive and negative | Positive and negative |
| Expected values | Each control has a quoted<br>mean value derived from<br>a minimum of 10 assays<br>and a standard deviation<br>anticipated for single<br>determinations of each<br>control in a number of<br>different laboratories<br>using different reagent<br>lots. Values are lot<br>specific | Each control has a quoted<br>mean value derived from<br>a minimum of 10 assays<br>and a standard deviation<br>anticipated for single<br>determinations of each<br>control in a number of<br>different laboratories<br>using different reagent<br>lots. Values are lot<br>specific |

Table 1. Comparison of New Device and Predicate Device

### Summary of Assessment of Performance Data 2.1.8

The new device is the same as the predicate device with the addition of data that supports a modification in the Intended Use. Additional data demonstrate the use of the controls to assess the performance of the Vitros Immunodiagnostic Products HBsAg assay when determining the qualitative

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detection of HBsAg in human plasma (EDTA, citrate and heparin) in addition to serum. Included in this 510(k) submission is the technical report that describes the assessment of multiple samples collected as either whole serum or in the presence of EDTA citrate or heparin. Each sample was tested either unspiked (negative) or spiked with known positive HBsAg plasma close to the weak positive detection level of the assay (positive). The results showed that all samples (serum, EDTA, citrate or heparin) behave similarly in the assay supporting that the controls can monitor the assay performance regardless of the tested sample matrix (serum or plasma).

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are simple and abstract, with smooth lines suggesting the shape of a head and face. The profiles are encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JAN 1 7 2003

Ms. Sarah Parsons Associate, Regulatory Affairs Ortho-Clinical Diagnostics. Inc. Regulatory Affairs MC00882 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: k030067

> Trade/Device Name: Vitros Immunodiagnostic Products HBsAg Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class I Product Code: MJX Dated: January 6, 2003 Received: January 7, 2003

Dear Ms. Parsons:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# 3.0 SUMMARY INFORMATION

#### Statement of Intended Use 3.1

Page 1 of 1

KU 30067 510(k) Number (if known):

Vitros Immunodiagnostic Products HBsAg Controls

Indications for Use:

Device Name:

For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate and heparin). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays.

For in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie Lu. Poole

n of Clinical Laboratory Devices

510(k) Number K030067

Prescription Use

OR

Over-The-Counter Use _

Ortho-Clinical Diagnostics, Inc.