ADVIA CENTAUR HAVM ASSAY

K081716 · Siemens Healthcare Diagnostics, Inc. · LOL · Jul 17, 2008 · Microbiology

Device Facts

• Record ID: K081716
• Device Name: ADVIA CENTAUR HAVM ASSAY
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: LOL · Microbiology
• Decision Date: Jul 17, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3310
• Device Class: Class 2

Intended Use

The ADVIA Centaur HAV IgM assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (EDTA, lithium heparinized, or sodium heparinized) using the ADVIA Centaur® System. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.

Device Story

In vitro diagnostic immunoassay; detects IgM response to hepatitis A virus in human serum or plasma. Uses ADVIA Centaur system; reagents include mouse anti-HAV human IgM monoclonal antibody (fab2 fragment) labeled with acridinium ester, streptavidin-coated paramagnetic microparticles, and inactivated purified HAV. Operates via automated immunoassay workflow; clinician orders test; laboratory technician processes samples on ADVIA Centaur system. Output is qualitative determination of HAV IgM; aids physicians in diagnosing acute or recent HAV infection. Benefits patient by providing timely diagnostic information for clinical management of hepatitis A.

Clinical Evidence

Bench testing only. Validation activities performed per risk analysis to address false positive rates; results demonstrated predetermined acceptance criteria were met.

Technological Characteristics

In vitro diagnostic immunoassay; utilizes monoclonal anti-HAV antibody F(ab)2 fragment; buffer composition uses EPPS. Fundamental scientific technology consistent with predicate.

Indications for Use

Indicated for the qualitative detection of IgM antibodies to hepatitis A virus (HAV) in human serum or plasma to aid in the diagnosis of acute hepatitis A infection.

Regulatory Classification

Identification

HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.

Special Controls

*Classification.* Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.

Predicate Devices

• ADVIA Centaur HAV IgM assay (K081716)

Submission Summary (Full Text)

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Siemens Healthcare Diagnostics Inc. 510(k) Premarket Notification - ADVIA Centaur® HAVM Assay

K081716

### 510(k) Summary ADVIA Centaur® HAVM Assay

JUL 1 7 2008

### 1. Manufacturer's Name, Address, Telephone, and Contact Person

Manufacturer

Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, New York 10591-5097

Contact Information:

Mary Seeger Manager, Requlatory Affairs Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, New York 10591-5097

Phone: [phone] Fax : [phone]

# 2. Date Summary Prepared:

June 10, 2008

### 3. Device Trade Name / Common Name

Common Name: IgM Antibody to Hepatitis A Virus (Anti-HAV IgM Assay) ADVIA Centaur® HAV IgM ReadyPack Reagents Trade Name: ADVIA Centaur® HAV IgM ReadyPack Calibrators FDA Classification: Class II (special controls)

#### Device Classification Name: Hepatitis A Test IgM Antibody 4.

#### 5. Intended Use:

The ADVIA Centaur HAV IgM assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (EDTA, lithium heparinized, or sodium heparinized) using the ADVIA Centaur® System. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.

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### 6. Device Description

The modified ADVIA Centaur® HAV IgM Assay is comprised of the following:

1. ADVIA Centaur HAV IgM ReadyPack primary reagent pack is composed of three components:

Lite Reagent - Mouse anti-HAV human IgM monoclonal antibody labeled with acridinium ester in . buffer with bovine serum albumin and preservatives. The modified device uses the fab2 fragment of the monoclonal antibody

- Solid Phase Streptavidin coated paramagnetic microparticles with bovine serum albumin and . preservatives
- Ancillary Well Reagent Inactivated purified hepatitis A virus (<0.1 ug/ml) in buffer with bovine . serum albumin and preservatives

2. ADVIA Centaur HAV IgM Readypack ancillary reagent pack containing ADVIA Centaur HAV IgM Ancillary Reagent which is composed of biotinylated mouse monoclonal to anti-human IgM in buffer with bovine serum albumin and preservatives.

3. ADVIA Centaur HAV IgM Calibrators

### 7. Substantial Equivalence

The modified ADVIA Centaur HAV IgM assay has the same operating principles, design, method of manufacture, assay performance characteristics and intended use as the predicate device. The modified ADVIA Centaur HAV IgM assay is substantially equivalent to the predicate ADVIA Centaur HAV IgM assay.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 7 2008

Siemens Healthcare Diagnostics Inc. C/O Mary Seeger, Ph.D. Manager, Regulatory Affairs 511 Benedict Avenue Tarrytown, New York 10592

Re: k081716

Trade/Device Name: ADVIA Centaur HAVM Assay Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A IgM Regulatory Class: Class II Product Code: LOL Dated: June 16, 2008 Received: June 18, 2008

Dear Dr. Seeger:

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. Insting 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 (OS) regulation (21 CFR Part 820).

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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Sally attaym

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

510(k) Number (if known): K081716

Device Name: ADVIA Centaur® HAV IgM ReadyPack Reagents ADVIA Centaur® HAV IgM Quality Control Materials

Indications for Use:

The ADVIA Centaur HAV IgM assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children.

WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Eyaluation (ODE)

Uve Schuf

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

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