# K132664: Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 16, 2013 after 50 days
- Product code: CJW (Bromcresol Purple Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K0861700: Dimension Clinical Chemistry System Albumin Flex reagent cartridge. Number could not be read

## Most influential descendants
- K151767: Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator (2015), 3 descendants of its own
- K222438: A-LYTE® Integrated Multisensor (IMT Na K Cl) (2023), 0 descendants of its own
- K222116: Atellica® CI Analyzer,  Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (2023), 0 descendants of its own
- K193001: Albumin BCP (2019), 0 descendants of its own
- K161954: Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) (2017), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K132664
Methodology: https://510kreport.com/methodology