DIMENSION CLINICAL CHEMISTRY SYSTEM

K112999 · Siemens Healthcare Diagnostics · JJE · Nov 22, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112999
• Device Name: DIMENSION CLINICAL CHEMISTRY SYSTEM
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JJE · Clinical Chemistry
• Decision Date: Nov 22, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Indications for Use

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.

Device Story

Floor-model, fully automated, microprocessor-controlled clinical chemistry analyzer; processes human body fluid samples in random access, batch, or stat modes. Uses prepackaged Flex® reagent cartridges; performs pipetting, mixing, heating, and spectral intensity measurements. Employs photometric, turbidimetric, and integrated ion-selective multisensor (Na, K, Cl) technologies. Operated by laboratory personnel in clinical settings; communicates with laboratory information systems (LIS). Revision 10.0 software migrates system from QNX to Linux OS; utilizes USB for data storage and RoHS-compliant circuit boards. Provides automated analysis of analytes to assist healthcare providers in diagnosing and monitoring disease states; benefits patients through rapid, standardized diagnostic testing.

Clinical Evidence

Bench testing only. Includes representative method comparison studies to verify performance consistency following software and hardware modifications. Design control activities and FMEA risk analysis performed to validate changes.

Technological Characteristics

Floor-model analyzer; photometric, turbidimetric, and ion-selective multisensor detection; quartz/halogen lamp source with interference filters; 37°C reaction temperature control; Linux OS (revision 10.0); USB data storage; RoHS-compliant printed circuit boards; LIS connectivity.

Indications for Use

Indicated for in vitro diagnostic measurement of analytes in human body fluids to aid in diagnosis and treatment of metabolic, thyroid, pituitary, liver, and heart disorders, including diabetes mellitus, hypoglycemia, and electrolyte imbalances.

Regulatory Classification

Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Predicate Devices

• Dimension® RxL/RxL Max clinical chemistry analyzer (with QNX Operating System) (K963498)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k112999

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k963498 (Dimension RxL/RxL Max clinical chemistry analyzer with QNX Operating System).

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the Dimension RxL/ RxLMax and Xpand /Xpand Plus clinical chemistry analyzers:

A. To change the software operating system from QNX to Linux.

B. To replace floppy disks with USB memory sticks as storage devices

C. To replace various printed circuit boards with RoHS (European Reduction of Hazardous Substances Directive) compliant boards.

D. To make minor changes for ease of use and interface improvements.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics user interface, detection technologies, reagents, system fluids, reaction vessels, temperature control, spectral selection, test throughput, LIS external connectivity capability, system performance monitoring, sample level detection capability, calibration, quality control, and sample integrity monitoring. Studies include a representative method comparison.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. FMEA

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.