(87 days)
No
The device description and performance studies focus on a standard immunoassay for detecting antibodies, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic immunoassay intended for the qualitative determination of IgM response to the hepatitis A virus, aiding in the diagnosis of infection, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended for use as an aid in the diagnosis of acute or recent infection... with hepatitis A virus."
No
The device description clearly outlines physical reagent kits, calibrators, and master curve cards, indicating it is a hardware-based immunoassay system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The ADVIA Centaur® HAV (gM (aHAVM) assay is an in vitro diagnostic immunoassay..."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems:
The ADVIA Centaur HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur XP, and ADVIA Centaur XPT 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, or patients less than 2 years of age.
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.
ADVIA Centaur CP system:
The ADVIA Centaur HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP 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, or patients less than 2 years of age.
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 ADVIA Centaur HAV IgM reagent kit contains the following:
- ReadyPack® primary reagent pack containing ADVIA Centaur HAV IgM Lite Reagent, Solid Phase Reagent, and Ancillary Well Reagent
- ReadyPack ancillary pack containing ADVIA Centaur HAV IgM Ancillary Reagent
- ADVIA Centaur HAV IgM Low Calibrator
- ADVIA Centaur HAV IgM High Calibrator
- ADVIA Centaur systems HAV IgM Master Curve cards
- ADVIA Centaur systems HAV IgM Calibrator Assigned Value Card
The HAV IgM ReadyPack consists of the following:
Primary reagent pack
- The Lite Reagent is an anti-HAV mouse monoclonal antibody (F(ab) ¿ fragment: ~0.3 µg/mL) labeled with acridinium ester in buffer with bovine serum albumin, surfactant, sodium azide (
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.
October 13, 2016
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Siemens Healthcare Diagnostics, Inc. Philip Liu, Ph.D. Director, Regulatory Affairs and Compliance 511 Benedict Avenue Tarrytown, NY 10591
Re: K161964
Trade/Device Name: ADVIA Centaur® HAV lgM Assay Regulation Number: 21 CFR §866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: II Product Code: LOL Dated: July 14, 2016 Received: July 18, 2016
Dear Dr. Liu:
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 misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Steven R. Gitterman -S
for Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161964
Device Name ADVIA® Centaur HAV IgM (aHAVM) Assay
Indications for Use (Describe)
ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems:
The ADVIA Centaur® HAV (gM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur XP, and ADVIA Centaur XPT 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, or patients less than 2 years of age.
ADVIA Centaur CP system:
The ADVIA Centaur® HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP 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, or patients less than 2 years of age.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary for the
ADVIA® Centaur Hepatitis A IgM (aHAVM) Assay
This 510(k) summary is being submitted in accordance with 21 CFR 807.92.
A. 510(k) Number: K161964
B. Date of Preparation: October 11, 2016
C. Proprietary and Established Names:
ADVIA® Centaur HAV IgM (aHAVM) Assay
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Philip Liu, Director, Requlatory Affairs and Compliance Office: (914) 524-2443 Fax: (914) 524-3579
E. Regulatory Information:
-
- Regulation section: 21 CFR § 866.3310; Hepatitis A virus (HAV) serological assays
-
- Classification: Class II
-
- Product Code: LOL
-
- Panel: Microbiology
F. Purpose of this Submission
The purpose of this submission is to add the pediatric populations to the Intended Use statement of the ADVIA Centaur HAV IgM assay cleared under K081716 (originally approved under PMA, P040018).
G. Predicate Device:
The ADVIA® Centaur HAV IgM Assay is substantially equivalent to the VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack cleared under 510(k): K060770
H. Device Description:
The ADVIA Centaur HAV IgM reagent kit contains the following:
- ReadyPack® primary reagent pack containing ADVIA Centaur HAV IgM Lite Reagent, Solid Phase Reagent, and Ancillary Well Reagent
- ReadyPack ancillary pack containing ADVIA Centaur HAV IgM Ancillary Reagent
- ADVIA Centaur HAV IgM Low Calibrator ●
- ADVIA Centaur HAV IgM High Calibrator ●
- ADVIA Centaur systems HAV IgM Master Curve cards .
- ADVIA Centaur systems HAV IgM Calibrator Assigned Value Card ●
4
The HAV IgM ReadyPack consists of the following:
Primary reagent pack
- The Lite Reagent is an anti-HAV mouse monoclonal antibody (F(ab) ¿ fragment: ~0.3 µg/mL) labeled with acridinium ester in buffer with bovine serum albumin, surfactant, sodium azide (