# K073604: Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 13, 2008 after 83 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970389 (1997). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053531: Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator, Dade Behring, Inc. (2006) Summary page 1.
- (no number) Dimension® RxL Max® clinical chemistry system: named in the summary without a submission number

## Most influential descendants
- K130276: Dimension Exl with LM System (2013), 1 descendant of its own
- K243570: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (2025), 0 descendants of its own
- K140842: Dimension Loci Free Thyroxine Flex Reagent Cartridge, FT4L, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart (2014), 0 descendants of its own
- K100778: Dimension Exl Loci Thyroid Calibrator, Model RC 610A (2010), 0 descendants of its own
- K081103: Loci Thyroid Calibrator with Model RC610 (2008), 0 descendants of its own

## Recalls of this device
- Apr 2, 2015 · Class II · Z-1615-2015: Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been installed with a non-standard instrument power plug.The use of a non-standard plug configuration as describ
- May 27, 2014 · Class III · Z-2133-2014: There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a
- Feb 27, 2013 · Class III · Z-1046-2013: Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Sieme
- Feb 27, 2013 · Class III · Z-1047-2013: Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Sieme
- Feb 27, 2013 · Class III · Z-1048-2013: Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Sieme
- Apr 12, 2010 · Not classified · Z-0458-2011: Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate t
- Sep 30, 2008 · Not classified · Z-0581-2009: Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or both HM wash probes are totally occluded.

## Indications for use
The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease. The LOCI® Thyroid Calibrator is an in vitro diagnostic product for the calibration of the FT4L method on the Dimension® EXLTM with LM system. The Dimension® EXLTM with LM system is an in vitro diagnostic device that is intended to measure a variety of analytes in human body fluids. The system utilizes photometric, turbidimetric, chemiluminescence and integrated ion selective multisensor technology for chemical and immunochemical applications for clinical use.

Source page: https://510kreport.com/device/K073604
Methodology: https://510kreport.com/methodology