510(k) · Cleared
Recalled · 2010Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jun 12, 1998 as substantially equivalent to K891475 (Bio-Rad, 1989) after a 16-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 12, 1998
- Review
- 16 days
- Class
- Class I
- Product code
- JJX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891475 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
- This deviceK981864 Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219Beckman Coulter, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK994277 Access Ostase QCBeckman Coulter, Inc. · 2000 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K994277Access Ostase QCBeckman Coulter, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 | Bio-Rad | 1989 | — |
| 0 (this device) | K981864 | Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219 | Beckman Coulter, Inc. | 1998 | — |
| +1 | K994277 | Access Ostase QC | Beckman Coulter, Inc. | 2000 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 JJX? 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 |
|---|---|---|---|
| * | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Summary page 1…Submission Date: May 26, 1998 2. Predicate Device Lyphochek® Immunoassay Control Serum Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, CA 92806 510(k) Number: K891475 3. Device Description The Access AFP QC are tri-level controls consisting of human AFP in human serum with preservatives. They a… | 1989 |
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 |
|---|---|---|---|
| K994277 | Access Ostase QC | 2000 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2010 | Not classified | Z-2208-2010 | Other | The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACCESS® AFP QC (serum based) are tri-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the ACCESS Immunoassay System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981864: Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981864
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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