510(k) · Cleared
ClearedQuickelisa Anthrax-PA Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunetics, Inc. · NRL Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Cleared on Jun 3, 2004 after a 107-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 3, 2004
- Review
- 107 days
- Class
- Class II
- Product code
- NRL
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Preamendments modified agar diffusion assay Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NRL devicesNRL Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRL
FDA has decided no NRL device since 2007.
Median 510(k) review, days · NRL
Too few NRL 510(k)s in any year since 2007 to give a median.
Recalls per year · NRL
No recall names NRL since 2007.
Adverse event reports per year · NRL
No MAUDE report names NRL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (235 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040407: Quickelisa Anthrax-PA Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040407
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026