VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS

K033127 · Ortho-Clinical Diagnostics · JJX · Oct 31, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033127
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Vitros Anti-HBc Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.

Device Story

Vitros Anti-HBc Controls consist of two levels of human plasma-based controls; Control 1 is normal human plasma; Control 2 is anti-HBc positive plasma diluted in normal human plasma. Both contain antimicrobial agents. Used in clinical laboratory settings to monitor performance of Vitros ECi Immunodiagnostic System. Controls are assigned values derived from a minimum of 10 assays; standard deviation reflects anticipated single determinations across multiple laboratories and reagent batches. Healthcare providers use these controls to estimate precision and detect systematic deviations in testing procedures, ensuring reliability of patient anti-HBc qualitative detection results.

Clinical Evidence

No clinical data. Performance established via bench testing; assigned values derived from a minimum of 10 assays across multiple laboratories and reagent batches to determine mean and standard deviation.

Technological Characteristics

Human plasma-based control material; contains antimicrobial agents. Two-level control system. Assigned values determined via multi-laboratory assay testing. Standalone quality control product.

Indications for Use

Indicated for monitoring the performance of the Vitros ECi Immunodiagnostic System during in vitro qualitative detection of total anti-HBc (IgG and IgM) in human serum and plasma (EDTA and citrate).

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

• Blackhawk BioSystems, Inc. VIROTROL® I (BK930016)

Submission Summary (Full Text)

{0}------------------------------------------------

## OCT 3 1 2003

# Chapter 1 -- Summary Information

## 510(k) Summary

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: K63 3127

#### 1. Submitter name, address, contact

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

Contact Person: Sarah Parsons

Date 510(k) prepared: September 29, 2003

#### Device Name 2.

Trade or Proprietary Name: Vitros Immunodiagnostic Products Anti-HBc Controls Common Name: anti-HBc controls Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed).

#### 3. Predicate Device

The Vitros Immunodiagnostic Products Anti-HBc Controls are substantially equivalent to Blackhawk BioSystems, Inc. VIROTROL® I (BK930016).

#### 4. Device Description

Vitros Anti-HBc Controls contain two levels of controls in separate vials.

Control 1

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

#### Control 2

Anti-HBc positive plasma diluted in normal human plasmas were obtained from donors who were tested individually and found to be negative HBsAg. and for antibodies to

{1}------------------------------------------------

HIV 1+2 and HCV using FDA approved methods (enzyme immunoassays). The anti-HBc positive plasma has also been tested and shown to be positive for anti-HBc antibody.

Both controls contain antimicrobial agent.

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.

#### 5. Device Intended Use

The Vitros Anti-HBc Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.

#### 6. Comparison to Predicate Device

The Vitros Immunodiagnostic Products Anti-HBc Controls are substantially equivalent to Blackhawk BioSystems, Inc. VIROTROL® I (BK930016).

Table 1 lists the similarities and differences of the device characteristics between the Vitros Anti-HBc Controls and the predicate device.

{2}------------------------------------------------

| | Table 1 Characteristics of the Controls | | |
|--|-----------------------------------------|--|--|
|--|-----------------------------------------|--|--|

| Characteristics | New Device | Predicate Device | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in monitoring the<br>performance of the Vitros ECi<br>Immunodiagnostic System when<br>used for the <i>in vitro</i> qualitative<br>detection of total antibody (IgG<br>and IgM) to hepatitis B core<br>antigen (total anti-HBc) in human<br>serum and plasma (EDTA and<br>citrate). The performance of the<br>Vitros Immunodiagnostic<br>Products Anti-HBc Controls has<br>not been established with any<br>other anti-HBc assays. | VIROTROL I is intended for use with in<br><i>vitro</i> assay procedures for determination<br>of antibodies to Human<br>Immunodeficiency Virus Type 1 (HIV-1),<br>antibodies to Human T-Lymphotropic<br>Virus Type I (HTLV-I), antibodies to<br>Hepatitis C Virus (HCV), Hepatitis B<br>Surface Antigen (HBsAg), antibodies to<br>Hepatitis B Core Antigen (HBc) and<br>antibodies to cytomegalovirus (CMV).<br>VIROTROL reagents are intended to<br>provide a means of estimating precision<br>and have the potential for detecting<br>systematic deviations from specific<br>laboratory testing procedures. | |
| | Matrix of controls | Human serum with added<br>antimicrobial agents | Human serum or plasma with added<br>stabilizers and preservative. |
| | | Control levels | Positive and negative |
| | Expected values | Each control has a quoted mean<br>value derived from a minimum of<br>10 assays and a standard<br>deviation anticipated for single<br>determinations of each control in<br>a number of different laboratories<br>using different reagent lots.<br>Values are lot specific. | VIROTROL 1® controls do not have<br>assigned values, but are formulated to<br>produce positive reactivity in the listed<br>manufacturer's assays. Specific levels of<br>reactivity will vary among different<br>manufacturers' assays, different<br>procedures, different reagent lot numbers,<br>and different laboratories. Each laboratory<br>should establish its own range of<br>acceptable values for each analyte. |

### 7. Conclusions

The information presented in the pre-market notification demonstrates that the Vitros Anti-HBc Controls are substantially equivalent to the predicate device Blackhawk BioSystems, Inc. VIROTROL 1® Multi-Marker Positive Control which was cleared by FDA (BK930016).

The information presented in the premarket notification provide a reasonable assurance that the Vitros Anti-HBc Controls are safe and effective for the stated intended use.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 3 1 2003

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

Re: k033127

> Trade/Device Name: Vitros Immunodiagnostic Products Anti-HBc Controls Regulation Number: 21 CFR 866.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 29, 2003 Received: September 30, 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).

{4}------------------------------------------------

#### 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 Sutman

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

{5}------------------------------------------------

## Indications for Use Statement

## 510(k) Number (if known):

K033127

Device Name:

Vitros Immunodiagnostic Products Anti-HBc Controls

Indications for Use:

For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human serum and plasma (EDTA and citrate). The performance of the Vitros Immunodiagnostic Products Anti-HBc Controls has not been established with any other anti-HBc assays.

Page 1 of 1

(PLEASE DO NOT WRITE BENGLE CONTINUE ON ANOTHER PAGE IF NEEDED)

,在""

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

Division Sign-Off

| Prescription Use | | Office of In Vitro Diagnostic Device | Over-The-Counter Use |
|----------------------|--|--------------------------------------|----------------------|
| (Per 21 CFR 801.109) | | Evaluation and Safety | |
| | | (Optional Format 1-2-96) | |

510(k) K033127Onho-Clinical Diagnostics

2