# K112999: Dimension Clinical Chemistry System

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Nov 22, 2011 after 46 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- 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: 1 generation back to K963498 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963498: Ferr Flex Reagent Cartridge, Dade Chemistry Systems, Inc. (1997) Summary page 1.

## Recalls of this device
- Sep 28, 2018 · Class II · Z-0409-2019: Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potenti
- Jun 29, 2017 · Class II · Z-1651-2018: Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely dep
- Nov 10, 2015 · Class II · Z-0460-2016: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located
- Nov 10, 2015 · Class II · Z-0461-2016: Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located
- 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
- Jul 17, 2012 · Class II · Z-2182-2012: Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially

## Indications for use
Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used for diagnosis in diseases with high and low Potassium levels. Chloride measurements are primarily use to detect and treatment of metabolic disorders. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Thyroid stimulating hormone measurements are used in diagnosis of thyroid or pituitary disorders. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. The Dimension ® clinical chemistry system is an in vitro diagnostic device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. The Dimension system chemical and immunochemical applications utilize photometric, turbidimetric, and integrated ion selective multisensor technology for clinical use.

Source page: https://510kreport.com/device/K112999
Methodology: https://510kreport.com/methodology