510(k) · Cleared
ClearedAccess Intrinsic Factor Ab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LIG Radioassay, Intrinsic Factor Blocking Antibody
Cleared on May 3, 2024 as substantially equivalent to K033603 (Beckman Coulter, Inc., 2003) after a 39-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- May 3, 2024
- Review
- 39 days
- Class
- Class II
- Product code
- LIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K811927 (1982). No later device cites it as a predicate yet.
- Root · 2 generations backK811927 1F Blocking Antibody (57 CO) RadioassayCorning Medical & Scientific · 1982
- 1 generation backK033603 Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay…Beckman Coulter, Inc. · 2003
- This deviceK240800 Access Intrinsic Factor AbBeckman Coulter, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811927 | 1F Blocking Antibody (57 CO) Radioassay | Corning Medical & Scientific | 1982 | — |
| −1 | K033603 | Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems… | Beckman Coulter, Inc. | 2003 | — |
| 0 (this device) | K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | 2024 | — |
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 LIG? 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 |
|---|---|---|---|
| * | K033603 | Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models…Summary page 4…tion Name: Radioassay, vitamin b12 Classification Code: LIG Classification Regulation: 862.1810 Predicate Device Device Name: Access Intrinsic Factor Ab 510(k) Numbers: K033603 Device Description The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consist… | 2003 |
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.
What does this lineage say?
- The line of descent spans 42 years and passes through 2 companies; a new generation was cleared every 21.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LIG devicesLIG Radioassay, Intrinsic Factor Blocking Antibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIG
Too few LIG 510(k)s in any year since 2007 to give a median.
Recalls per year · LIG
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIG
1in 2019
MAUDE reports naming product code LIG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 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 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240800 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240800: Access Intrinsic Factor Ab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240800
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026