510(k) · Cleared
ClearedKronus, Inc.'S Acetylcholine Receptor Antibody (Achrab) Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kronus Market Development Associates, Inc. · NST Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
Cleared on Dec 17, 2004 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 17, 2004
- Review
- 120 days
- Class
- Class II
- Product code
- NST
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NST? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 NST devicesNST Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NST
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NST
Too few NST 510(k)s in any year since 2007 to give a median.
Recalls per year · NST
No recall names NST since 2007.
Adverse event reports per year · NST
No MAUDE report names NST 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 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 KRONUS Acetylcholine Receptor Antibody (AChRAb) Assay Kit is for the quantitative or qualitative determination of acetylcholine receptor antibody in human serum.
The KRONUS Acetylcholine Receptor Antibody(AChRAb) kit is useful as an aid in the differential diagnosis of Myasthenia Gravis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042248: Kronus, Inc.'S Acetylcholine Receptor Antibody (Achrab) Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042248
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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