# K040407: Quickelisa Anthrax-PA Kit

- Pathway: 510(k) (Traditional)
- Applicant: Immunetics, Inc.
- Decided: Jun 3, 2004 after 107 days
- Product code: NRL (Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis)
- Device class: 2
- Regulation: 21 CFR 866.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Preamendments modified agar diffusion assay: named in the summary without a submission number

## Indications for use
The Immunetics® QuickELISA Anthrax-PA Kit is intended for use in the qualitative detection of antibodies to the Protective Antigen (PA) protein of B. anthracis in human serum. The assay should be used only on serum samples from individuals with a clinical history, signs or symptoms consistent with anthrax infection as an aid in the diagnosis of anthrax, or from recipients of anthrax vaccine. * The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, and when possible other laboratory data, in addition to the presence of antibodies to B. anthracis PA. Negative results in ELISA should not be used in isolation from other evidence to exclude anthrax. * The assay has not been evaluated in individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed cutaneous or inhalation anthrax. There is no information available to interpret the meaning of a positive or negative test result for such individuals. * The assay has not been evaluated with specimens from patients infected by the gastrointestinal route; expected results with such infections are unknown. * The minimum level of anti-PA antibodies that confers protection following the vaccination is not known. The QuickElisa measures total antibody and the relationship between this value and protective immunity has not been established. * The affinity and/or avidity of anti-PA IgG and IgM for the rPA antigen have not been determined with this assay.

Source page: https://510kreport.com/device/K040407
Methodology: https://510kreport.com/methodology