510(k) · Cleared
ClearedInstrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999
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 Dec 19, 2003 as substantially equivalent to K811927 (Corning Medical & Scientific, 1982) after a 32-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.
- Decided
- Dec 19, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- LIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811927 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK811927 1F Blocking Antibody (57 CO) RadioassayCorning Medical & Scientific · 1982
- This deviceK033603 Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay…Beckman Coulter, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK240800 Access Intrinsic Factor AbBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240800Access Intrinsic Factor AbBeckman Coulter, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811927 | 1F Blocking Antibody (57 CO) Radioassay | Corning Medical & Scientific | 1982 | — |
| 0 (this device) | K033603 | Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems… | Beckman Coulter, Inc. | 2003 | — |
| +1 | K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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.
Top candidate predicates for a new LIG device
- #1 K240800 Access Intrinsic Factor Abscore 7.6 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K811927 | 1F Blocking Antibody (57 CO) RadioassaySummary page 1…lFbAb Diagnostic Products Corporation 5700 West 9 6 th Street Los Angeles, CA 90045-5597 510(k) Number: k811927 Beckman Coulter, Inc. Telephone: (952) 448-4848 1000 Lake Hazeltine Drive Internet: www.beckmancoult… | 1982 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240800 | Access Intrinsic Factor Ab | 2024 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K240800 (Beckman Coulter, Inc., 2024) has gone furthest, with 0 descendants of its own.
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.
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/K033603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033603: Instrinsic Factor AB, Calibrators, and QC on the Access Immunoassay Systems, Models 387992, 387993, 387999.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033603
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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