510(k) · Cleared
Recalled · Class II · 2019Albumin BCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · CJW Bromcresol Purple Dye-Binding, Albumin
Cleared on Jan 7, 1985 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 7, 1985
- Review
- 53 days
- Class
- Class II
- Product code
- CJW
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK844426 Albumin BCPBoehringer Mannheim Corp. · 1985
- Descendant · cites it directly · 1 of its ownK981814 ALBPAbbott Laboratories · 1998
- Descendant · 2 generations on · 0 of its ownK203530 Albumin BCP2Abbott Ireland Diagnostics Division · 2022
- Descendant · cites it directly · 0 of its ownK981457 ALBPAbbott Mfg., Inc. · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844426 | Albumin BCP | Boehringer Mannheim Corp. | 1985 | — |
| +1 | K981814 | ALBP | Abbott Laboratories | 1998 | — |
| +2 | K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | 2022 | — |
| +1 | K981457 | ALBP | Abbott Mfg., Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CJW? 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 CJW device
- #1 K203530 Albumin BCP2score 3.3 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2019 | Class II | Z-1194-2019 | Process control | The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981814 (Abbott Laboratories, 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CJW devicesCJW Bromcresol Purple Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJW
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · CJW
Too few CJW 510(k)s in any year since 2007 to give a median.
Recalls per year · CJW
No recall names CJW since 2007.
Adverse event reports per year · CJW
1in 2025
MAUDE reports naming product code CJW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K844426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K844426: Albumin BCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844426
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026