510(k) · Cleared
ClearedAlbumin BCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SENTINEL CH. SpA · CJW Bromcresol Purple Dye-Binding, Albumin
Cleared on Dec 19, 2019 as substantially equivalent to K132664 (Siemens Healthcare Diagnostics, Inc., 2013) after a 52-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Dec 19, 2019
- Review
- 52 days
- Class
- Class II
- Product code
- CJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132664 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK132664 Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin…Siemens Healthcare Diagnostics, Inc. · 2013
- This deviceK193001 Albumin BCPSENTINEL CH. SpA · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| 0 (this device) | K193001 | Albumin BCP | SENTINEL CH. SpA | 2019 | — |
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 |
|---|---|---|---|
| * | K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP CalibratorSummary page 5…-binding, albumin Governing Regulation: 21CFR862.1035 Product Code: CJW Panel: Clinical Chemistry (75) 5.4. Predicate Device ADVIA Chemistry BCP assay (ALBP) (k132664) 5.5. Intended Use of the Device The Albumin BCP assay is an in vitro diagnostic test used for the determination of album… | 2013 |
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 no recall.
- 1 other device also cites its predicate K132664.
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. 2019, this device’s year, is highlighted.
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 an in vitro diagnostic test used for the determination of albumin in human serum or plasma.
Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The assay is intended for professional use only.
For In Vitro Diagnostic use only.
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/K193001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193001: 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/K193001
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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