VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

K042303 · Ortho-Clinical Diagnostics · JJX · Sep 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042303
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.

Device Story

VITROS Immunodiagnostic Products Anti-HBs Controls consist of three levels of freeze-dried human serum-based controls (one negative, two positive) containing antimicrobial agents. Used in clinical laboratory settings to monitor performance of VITROS Immunodiagnostic System during quantitative anti-HBs testing. Controls are processed alongside patient samples; healthcare providers compare observed system results against assigned lot-specific mean values and standard deviations to verify assay accuracy and precision. Benefits include ensuring reliability of diagnostic results for Hepatitis B surface antigen antibodies.

Clinical Evidence

No clinical data. Bench testing only; performance established via assignment of mean values and standard deviations derived from a minimum of 10 assays across multiple laboratories using different reagent batches.

Technological Characteristics

Matrix: human serum with added constituents and antimicrobial agents. Three-level control set (negative and two positive). Traceability: WHO 1st International Reference Preparation (1977). Intended for use on VITROS ECi/ECiQ Immunodiagnostic System.

Indications for Use

Indicated for monitoring the performance of the VITROS Immunodiagnostic System during quantitative in vitro determination of total anti-HBs antibodies in human serum. For professional in vitro diagnostic use.

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 Anti-HBs Controls (k003112)

Submission Summary (Full Text)

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### GENERAL INFORMATION 2.0

### 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: K048303

### Submitter Name, Address, Contact 2.1.1

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

Sarah Glover Contact Person:

### Preparation Date 2.1.2

August 24, 2004 Date 510(k) Summary Prepared:

#### Device Name 2.1.3

Trade or Proprietary Name: VITROS Immunodiagnostic Products Anti-HBs Controls

Common Name:

Anti-HBs Controls

Classification Name:

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

### Predicate Device 2.1.4

The VITROS Immunodiagnostic Products Anti-HBs Controls are substantially equivalent to the current VITROS Immunodiagnostic Products Anti-HBs Controls (K003112).

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### Device Description 2.1.5

The VITROS Immunodiagnostic Products Anti-HBs Controls are comprised of three levels of controls in separate vials:

# Control 1 (Negative)

Anti-HBs negative plasma obtained from donors who were tested individually and found to be negative for hepatitis B surface antigen, and for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (enzyme immunoassays, EIA).

# Control 2 (Positive)

Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 25.00 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).

# Control 3 (Positive)

Anti-HBs negative plasma spiked with anti-HBs positive plasma to give a nominal VITROS Anti-HBs result of 380 mIU/mL. The positive plasma was obtained from donors who were tested individually and found to be negative for antibodies to human immunodeficiency virus (HIV 1+2) and hepatitis C virus (HCV) using FDA approved methods (EIA).

All controls contain antimicrobial agent and are freeze-dried.

The controls are assigned values from a minimum of 10 assays. The standard deviation is that which would be anticipated for single determinations of each control in a number of different laboratories using different reagent batches.

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#### Device Intended Use 2.1.6

The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.

### Comparison to Predicate Device 2.1.7

The VITROS Immunodiagnostic Products Anti-HBs Controls are substantially equivalent to the current VITROS Immunodiagnostic Products Anti-HBs Controls (K003112).

Table 1 lists the characteristics of the VITROS Immunodiagnostic Products Anti-HBs Controls (new device) and the current VITROS Immunodiagnostic Products Anti-HBs Controls (predicate device).

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| Table 1: Comparison of New Device and Predicate Device | | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | VITROS Immunodiagnostic<br>Products Anti-HBs Controls<br>(New device) | VITROS Immunodiagnostic<br>Products Anti-HBs Controls<br>(Predicate device) |
| Intended use | For use in monitoring the<br>performance of the VITROS<br>Immunodiagnostic System<br>when used for the quantitative<br><i>in vitro</i> determination of total<br>antibody to Hepatitis B surface<br>antigen (anti-HBs) in human<br>serum when using the<br>VITROS Immunodiagnostic<br>Products Anti-HBs<br>Quantitative Reagent Pack on<br>the VITROS<br>Immunodiagnostic System.<br>The performance of the<br>VITROS Immunodiagnostic<br>Products Anti-HBs Controls<br>has not been established with<br>any other anti-HBs assays. | For use in monitoring the<br>performance of the VITROS<br>Immunodiagnostic System<br>when used for the qualitative <i>in<br/>vitro</i> determination of total<br>antibody to Hepatitis B surface<br>antigen (anti-HBs) in human<br>serum when using the VITROS<br>Immunodiagnostic Products<br>Anti-HBs Reagent Pack on the<br>VITROS ECi<br>Immunodiagnostic System.<br>The performance of the<br>VITROS Immunodiagnostic<br>Products Anti-HBs Controls<br>has not been established with<br>any other anti-HBs assays. |
| Matrix of<br>controls | Human serum with added<br>constituents of human origin<br>and antimicrobial agents | Human serum with added<br>constituents of human origin<br>and antimicrobial agents |
| Control level | 2 Positive and 1 negative | 1 Positive and 1 negative |
| Expected values | Each control has a quoted<br>mean value derived from a<br>minimum of 10 assays and a<br>standard deviation anticipated<br>for single determinations of<br>each control in a number of<br>different laboratories using<br>different reagent lots. Values<br>are lot specific. | Each control has a quoted<br>mean value derived from a<br>minimum of 10 assays and a<br>standard deviation anticipated<br>for single determinations of<br>each control in a number of<br>different laboratories using<br>different reagent lots. Values<br>are lot specific |

| Table 1. Comparison of New Device and Predicate Device | | | |
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|--------------------------------------------------------|--|--|--|

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 7 2004

Ms. Sarah Glover Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626

Re: k042303

Trade/Device Name: VITROS Immunodiagnostic Products Anti-HBs Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: August 24, 2004 Received: August 25, 2004

Dear Ms. Glover:

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 r ou may 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, s you stons on the promotion and advertising of your device, please contact the Office of of questions on the promise Evaluation and Safety 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 Tod may 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,

Saqartys

Sally A. Hojvat, M.Sc., Ph.D. 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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### Indications for Use Statement 2.2

### Page 1 of 1

510(k) Number (if known):

K042303

Device Name:

VITROS Immunodiagnostic Products Anti-HBs Controls

Indications for Use:

The VITROS Immunodiagnostic Products Anti-HBs Controls are intended for use in monitoring the performance of the VITROS Immunodiagnostic System when used for the quantitative in vitro determination of total antibody to Hepatitis B surface antigen (anti-HBs) in human serum when using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack on the VITROS Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HBs Controls has not been established with any other anti-HBs assays.

For in vitro diagnostic use.

ﺮ, ﺍﻷ

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------|---------------------------------------|
| <div><img alt="signature" src="signature.png"/></div> | |
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510(k) | K042303 |
| Prescription Use | <div style="text-align:left;">✓</div> |
| (Per 21 CFR 801.109) | |
| | OR |
| Over-The-Counter Use | |
| | (Optional Format 1-2-96) |