510(k) · Cleared
ClearedALBP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Mfg., Inc. · CJW Bromcresol Purple Dye-Binding, Albumin
Cleared on May 27, 1998 as substantially equivalent to K844426 (Boehringer Mannheim Corp., 1985) after a 34-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- May 27, 1998
- Review
- 34 days
- Class
- Class II
- Product code
- CJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844426 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK844426 Albumin BCPBoehringer Mannheim Corp. · 1985 · Recalled
- This deviceK981457 ALBPAbbott Mfg., Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844426 | Albumin BCP | Boehringer Mannheim Corp. | 1985 | 1 |
| 0 (this device) | K981457 | ALBP | Abbott Mfg., Inc. | 1998 | — |
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 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? (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 |
|---|---|---|---|
| * | K844426 | Albumin BCPSummary page 1…l to the albumin concentration in the sample. Substantial Equivalence: The Albumin BCP assay is substantially equivalent to the Boehringer Mannheim® Albumin BCP Assay (K844426) on the Hitachi® 717 Analyzer. Both assays yield similar Performance Characteristics. Albumin BCP 510(k) Section II April 22, 1… | 1985 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K844426.
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 | — |
What is it indicated for?
The Albumin BCP assay is used for the quantitation of albumin in human serum.
Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.
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/K981457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981457: ALBP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981457
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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