VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS

K012561 · Ortho-Clinical Diagnostics · JJX · Aug 29, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012561
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
• Applicant: Ortho-Clinical Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Vitros Anti-HCV Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA or citrate). The performance of the Vitros Immunodiagnostic Products Anti-HCV Controls has not been established with any other anti-HCV assays.

Device Story

Vitros Anti-HCV Controls are quality control materials used to monitor the performance of the Vitros ECi Immunodiagnostic System. The system performs immunoassays using coated microwells as a solid phase separation system and luminescence as the detection signal. The controls consist of human serum with added antimicrobial agents and are provided in positive and negative levels. Each control has lot-specific mean values and standard deviations derived from multi-laboratory testing. The device is used by laboratory personnel to verify the accuracy and precision of the Vitros ECi system during the qualitative detection of anti-HCV antibodies. By monitoring system performance, the controls help ensure the reliability of patient test results, thereby supporting accurate clinical diagnosis and management of hepatitis C.

Clinical Evidence

No clinical data. Bench testing only. Performance established via comparison of lot-specific mean values and standard deviations derived from a minimum of 10 assays across multiple laboratories.

Technological Characteristics

Quality control material composed of human serum with added antimicrobial agents. Designed for use with the Vitros ECi Immunodiagnostic System, which utilizes luminescence-based immunoassay technology and coated microwell solid-phase separation. Values are lot-specific, derived from multi-laboratory testing.

Indications for Use

Indicated for monitoring the performance of the Vitros ECi Immunodiagnostic System during in vitro qualitative detection of IgG anti-HCV in human serum and plasma (heparin, EDTA, or 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

• Boston Biomedica, Inc. ACCURUN 1 Multi-Marker Positive Control (BK930027)

Submission Summary (Full Text)

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### AUG 2 9 2001

# 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: K012561

### 1. Submitter name, address, contact

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

Contact Person: Susan Werner

Date 510(k) prepared: August 6, 2001

#### Device Name 2.

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

#### 3. Predicate Device

5. I reducts be novels Anti-HCV Controls are substantially equivalent to Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control (BK930027).

#### 4. Device Description

The Virros Immunodiagnostic System uses luminescence as the signal in the qualitative detection The Pirod Hillians are many plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

- 1. The Viros Immunodiagnostic Products range of products, in this case Vitros Immunodiagnostic The / in of millians and Vitros Immunodiagnostic Products Calibrator, which are r routed by the Vitros Immunodiagnostic System to perform a Vitros assay. The Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator have been submitted for FDA review in PMA P010021.
3

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## 510(k) Summary, continued.

- 2. The Vitros Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The Vitros Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- 3. Common reagents used by the Vitros System in each assay. The Vitros Immunodiagnostic Products Signal Reagent and Vitros Immunodiagnostic Products Universal Wash Reagent were cleared as part of the Vitros Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).

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

#### 5. Device Intended Use

The Vitros Anti-HCV Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA or citrate). The performance of the Vitros Immunodiagnostic Products Anti-HCV Controls has not been established with any other anti-HCV assays.

#### 6. Comparison to Predicate Device

The Virros Immunodiagnostic Products Anti-HCV Controls are substantially equivalent to Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control (BK930027).

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

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| Characteristics | New Device | Predicate Device |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in monitoring the<br>performance of the <i>Vitros</i> ECi<br>Immunodiagnostic System when<br>used for the <i>in vitro</i> qualitative<br>detection of immunoglobulin G<br>antibody to hepatitis C virus<br>(anti-HCV) in human serum and<br>plasma (heparin, EDTA or<br>citrate). The performance of the<br><i>Vitros</i> Immunodiagnostic<br>Products Anti-HCV Controls has<br>not been established with any<br>other anti-HCV assays. | ACCURUN 1® controls are intended to<br>estimate laboratory testing precision and<br>can be used to detect errors in laboratory<br>testing procedures. ACCURUN 1® Multi-<br>Marker Positive Controls have been<br>formulated for use with <i>in vitro</i> diagnostic<br>test kits for the detection of antibodies to<br>Human Immunodeficiency Virus Types 1<br>and 2 (HIV 1 and 2), antibodies to Human<br>T-Lymphotropic Virus Types I and II<br>(HTLV I and II), antibodies to Hepatitis B<br>Core Antigen (HBcAg), antibodies to<br>Hepatitis C Virus (HCV), antibodies to<br>Cytomegalovirus (CMV), and Hepatitis B<br>Surface Antigen. A negative control for<br>these analytes is available separately from<br>BBI®. |
| 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 | Positive |
| 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. | As stated in the package insert,<br>ACCURUN 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-HCV Controls are substantially equivalent to the predicate device Boston Biomedica, Inc. ACCURUN 1® Multi-Marker Positive Control which was cleared by FDA (BK930027).

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### AUG 2 9 2001

Ms. Susan Werner Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

K012561 Re:

Trade/Device Name: Vitros Immunodiagnostic Products Anti-HCV Controls Regulation Number: 21 CFR 862.1660 Regulatory Class: I Product Code: JJX, MJY, MJX Dated: August 6, 2001 Received: August 8, 2001

Dear Ms. Werner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amerade over and to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothleadon. The I Dr I imailig of coation 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 and v additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 007:10 for in This anglestions on the promotion and advertising of your device, [phone]. Radinomal), at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibilities and its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Statement of Intended Use

Page 1 of 1

K012561

510(k) Number (if known):

Device Name:

Vitros Immunodiagnostic Products Anti-HCV 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 immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA or citrate). The performance of the Vitros Immunodiagnostic Products Anti-HCV Controls has not been established with any other anti-HCV assays.

Woody Dubois

ision of Cimical Laboratory Devices, 01256 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)