VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

K032993 · Ortho-Clinical Diagnostics, Inc. · JJX · Oct 31, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032993
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• 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 Immunodiagnostic Products Anti-HBc IgM Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of IgM antibody to Hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (heparin, EDTA or citrate). For in vitro diagnostic use.

Device Story

Vitros Immunodiagnostic Products Anti-HBc IgM Controls consist of two levels of freeze-dried human plasma: a negative control (normal human plasma) and a positive control (normal human plasma spiked with anti-HBc IgM positive plasma). Both controls are screened negative for HIV 1+2, HCV, and HBsAg. Used in clinical laboratories to monitor the performance of the Vitros ECi Immunodiagnostic System. Healthcare providers use the control results to verify the accuracy and precision of the diagnostic system before testing patient samples. The device ensures the reliability of the qualitative detection of anti-HBc IgM, aiding in the clinical assessment of Hepatitis B infection status.

Clinical Evidence

No clinical data. Bench testing only; controls are assigned values based on a minimum of 10 assays to determine expected standard deviation across different laboratories and reagent batches.

Technological Characteristics

Freeze-dried human plasma controls containing antimicrobial agents. Two-level configuration (negative and positive). Assigned values derived from multi-laboratory testing. Standalone quality control material.

Indications for Use

Indicated for use as an assayed quality control material to monitor the performance of the Vitros ECi Immunodiagnostic System for the qualitative detection of anti-HBc IgM in human serum and plasma.

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 III (K974613)

Submission Summary (Full Text)

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#### GENERAL INFORMATION 2.0

# OCT 3 1 2003

#### 2.1 510(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: K032993

#### 2.1.1 Submitter Name, Address, Contact

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

Contact Person: Sarah Parsons

#### Preparation Date 2.1.2

Date 510(k) Summary Prepared:

#### 2.1.3 Device Name

Trade or Proprietary Name: Vitros Immunodiagnostic Products Anti-HBc IgM Controls

Anti-HBc IgM Controls Common Name:

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

#### Predicate Device 2.1.4

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are substantially equivalent to Blackhawk BioSystems, Inc Virotrol III (K974613).

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#### Device Description 2.1.5

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are comprised of two levels of controls in separate vials:

### Control 1 (Negative)

Normal human 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)

Normal human plasma spiked with anti-HBc IgM positive plasma. 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).

Both 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 31 2003

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

Re: k032993

Trade/Device Name: Vitros Immunodiagnostic Products Anti-HBc IgM Controls Regulation Number: 21 CFR 866.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 24, 2003 Received: September 25, 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 misb. anding and adulteration.

If vour 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 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

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#### 2.2 Indications for Use Statement

Page 1 of 1

Ko32993 510(k) Number (if known):

Device Name:

Vitros Immunodiagnostic Products Anti-HBc IgM Controls

Indications for Use:

The Vitros Immunodiagnostic Products Anti-HBc IgM Controls are intended for use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of IgM antibody to Hepatitis B core antigen (anti-HBc IgM) in human serum and plasma (heparin, EDTA or citrate). For in vitro diagnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span></span> |
|------------------------------------------|---------------|
|------------------------------------------|---------------|

| OR | Over-The-Counter Use |
|-------------------|--------------------------|
| Division Sign-Off | (Optional Format 1-2-96) |

Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K032993 |
|--------|---------|
|--------|---------|