510(k) · Cleared

Cleared

Albumin BCP2

K203530510(k) TraditionalCleared Mar 18, 2022471-day reviewClass II21 CFR 862.1035

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Ireland Diagnostics Division · CJW Bromcresol Purple Dye-Binding, Albumin

Cleared on Mar 18, 2022 as substantially equivalent to K981814 (Abbott Laboratories, 1998) after a 471-day review. Its family tree reaches back 2 generations to 1985.

Decided: Mar 18, 2022
Review: 471 days
Class: Class II
Product code: CJW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K844426 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK844426 Albumin BCPBoehringer Mannheim Corp. · 1985 · Recalled
1 generation backK981814 ALBPAbbott Laboratories · 1998
This deviceK203530 Albumin BCP2Abbott Ireland Diagnostics Division · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K844426	Albumin BCP	Boehringer Mannheim Corp.	1985	1
−1	K981814	ALBP	Abbott Laboratories	1998	—
0 (this device)	K203530	Albumin BCP2	Abbott Ireland Diagnostics Division	2022	—

FIG. 1 — Lineage of K203530, 1985–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K981814	ALBP Summary page 5 …ion: Class II Classification Name: Albumin test system Governing Regulation Number: 21 CFR 862.1035 Product Code: CJW IV. Predicate Device Albumin BCP (k981814) V. Description of Device A. Principles of the Procedure The Albumin BCP2 assay is an automated clinical chemistry…	Abbott Laboratories	1998	—
†	K980367	Aeroset System	Abbott Laboratories	1998	34

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?

The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 23.7 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All CJW devices

CJW Bromcresol Purple Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · CJW

1in 2022

2007high 1 (2013) · low 0 (2007)2026

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

2007high 5 (2021) · low 0 (2008)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	MAUDE reports
2007	0	—	1
2008	0	—	0
2009	0	—	1
2010	0	—	1
2011	0	—	1
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	1
2018	0	—	0
2019	1	—	3
2020	0	—	0
2021	0	—	5
2022	1	—	0
2023	0	—	2
2024	0	—	1
2025	0	—	1
2026	0	—	—

What is it indicated for?

The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K203530 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203530: Albumin BCP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203530

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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