510(k) · Cleared
ClearedAdvia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CJW Bromcresol Purple Dye-Binding, Albumin
Cleared on Oct 16, 2013 after a 50-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Oct 16, 2013
- Review
- 50 days
- Class
- Class II
- Product code
- CJW
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 2 citing it directly.
- This deviceK132664 Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK151767 Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI)…Siemens Healthcare Diagnostics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK222438 A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK222116 Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone…Siemens Healthcare Diagnostics, Inc. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK193001 Albumin BCPSENTINEL CH. SpA · 2019
- Descendant · 2 generations on · 0 of its ownK161954 Atellica Solution, Atellica A-LYTE Integrated Multisensor…Siemens Healthcare Diagnostics · 2017 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K151767Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A…Siemens Healthcare Diagnostics, Inc. · 2015 · cites it directly3descendants
- K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K193001Albumin BCPSENTINEL CH. SpA · 2019 · cites it directly0descendants
- K161954Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH…Siemens Healthcare Diagnostics · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +1 | K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT… | Siemens Healthcare Diagnostics, Inc. | 2015 | 12 |
| +2 | K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +2 | K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra… | Siemens Healthcare Diagnostics, Inc. | 2023 | 1 |
| +1 | K193001 | Albumin BCP | SENTINEL CH. SpA | 2019 | — |
| +2 | K161954 | Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica… | Siemens Healthcare Diagnostics | 2017 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0861700 | Dimension Clinical Chemistry System Albumin Flex reagent cartridge Number could not be read |
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151767 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 3 descendants 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. 2013, 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?
For in vitro diagnostic use in the quantitative measurement of albumidn in human serum or plasma on AD VIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
For in vitro diagnostic use in the calibration of' the AD VIA Chemistry Albumin BCP Assay (ALBP-) on ADVIA Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132664: Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132664
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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