Architect HAVAB-G
by Abbott Laboratories 510(k)
Active
510(k) K113704
Overview
The Architect HAVAB-G is an in vitro diagnostic device classified as a Hepatitis A Test (Antibody and IgM Antibody), designed for the qualitative detection of IgG and IgM antibodies to hepatitis A virus in human serum. It aids in determining an individual’s immune status to hepatitis A virus infection by identifying the presence of these antibodies in adult and pediatric patients.
This assay is intended for use on the Architect i System and is supplied as a single-use reagent kit. It is regulated under FDA 510(k) clearance (K113704) and falls under the medical specialty of microbiology. The device is not sterile and must be stored and handled according to manufacturer guidelines to ensure accurate and reliable test results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113704 | Date28 Jun 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1728-2020
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
-
- Terminated Z-0574-2020
Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.
Specification
- 510(k) Number
- FDA Product Code
- LOL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3310
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the Architect HAVAB-G test, and who is it designed for?
The Architect HAVAB-G is designed to qualitatively detect IgG and IgM antibodies to the hepatitis A virus in human serum, helping determine an individual’s immune status to hepatitis A infection. It is intended for use in both adult and pediatric patients to identify past or current exposure to the virus.
How is the Architect HAVAB-G supplied, and is it intended for single-use?
The Architect HAVAB-G is supplied as a single-use reagent kit, meaning each test requires a new kit. This ensures accuracy and prevents cross-contamination, as reuse is not recommended or supported by the manufacturer.
Is the Architect HAVAB-G sterile, and what storage guidelines should be followed?
The Architect HAVAB-G is explicitly stated as not sterile, so it must be handled with care to avoid contamination. Storage and handling should strictly follow the manufacturer’s guidelines to maintain test reliability, though specific conditions (e.g., temperature) are not detailed in the provided data.
On which system does the Architect HAVAB-G run, and what regulatory pathway was used for its clearance?
The test is intended for use exclusively on the Architect i System, a platform designed for in vitro diagnostics. It received FDA 510(k) clearance (K113704) under the traditional review pathway, with a determination of substantial equivalence to a predicate device, as classified under medical specialty microbiology.