(29 days)
Not Found
No
The description focuses on the immunoassay components and the ADVIA Centaur System, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic immunoassay used for the qualitative determination of IgM response to the hepatitis A virus, aiding in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "an aid in the diagnosis of acute or recent infection... with hepatitis A virus."
No
The device description clearly outlines physical reagents (Lite Reagent, Solid Phase, Ancillary Well Reagent, Ancillary Reagent, Calibrators) which are not software components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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..."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / 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.
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.
Product codes
LOL
Device Description
The modified ADVIA Centaur® HAV IgM Assay is comprised of the following:
- 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 (
§ 866.3310 Hepatitis A virus (HAV) serological assays.
(a)
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.(b)
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.
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Siemens Healthcare Diagnostics Inc. 510(k) Premarket Notification - ADVIA Centaur® HAVM Assay
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: 914-524-2908 Fax : 914-524-2500
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.
1
6. Device Description
The modified ADVIA Centaur® HAV IgM Assay is comprised of the following:
- 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 (