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

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 (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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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K081716

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. ADVIA Centaur HAV IgM Assay, P040018, down classified to Class II by the US FDA February 2006.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for

- Adjustment of the assay to address customer observed increased false positive rate as compared to other commercially available HAV IgM assay. These adjustments include:

1. The change of the monoclonal anti-HAV antibody from a whole IgG to and F(ab)2 fragment
2. Changing the buffer composition from Tricine to EPPS

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device included labeling, intended use, physical characteristics, and validation data.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity includes:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.