# K043546: Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Jan 18, 2005 after 26 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dimension RxL Max: named in the summary without a submission number

## Most influential descendants
- K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 (2009), 4 descendants of its own
- K082638: Advia Centaur System with Streamlab Analytical Workcell (2009), 4 descendants of its own
- K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own
- K093318: Accelerator Aps (2010), 3 descendants of its own
- K213486: GLP systems Track (2022), 1 descendant of its own

## Recalls of this device
- May 16, 2023 · Class II · Z-2091-2023: A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occ
- Oct 6, 2021 · Class II · Z-0193-2022: The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results cou
- Sep 1, 2009 · Not classified · Z-1205-2010: Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery seque

## Indications for use
The Dimension®'9 RxIL Max TM with StrCamLAl3B Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various sleps such as pipetting, preparing filtrates, heating, and measuring color inictnsitv. This device is intended for usc in conjunction with certain materials to micasure a variety of analyles.

Source page: https://510kreport.com/device/K043546
Methodology: https://510kreport.com/methodology