# K083339: Dimension RXL Max with Advia Modular Automation System (Amas)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 9, 2009 after 117 days
- Product code: CIC (Cresolphthalein Complexone, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860021 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944093: Dimension (R) XL Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1994) Summary page 1.
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.
- K043546: Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module, Dade Behring, Inc. (2005) Summary page 1.

## Indications for use
The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used. Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Source page: https://510kreport.com/device/K083339
Methodology: https://510kreport.com/methodology