DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

K043546 · Dade Behring, Inc. · CDT · Jan 18, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043546
• Device Name: DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
• Applicant: Dade Behring, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: Jan 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Indications for Use

The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate 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.

Device Story

The Dimension® RxL Max™ is a discrete, random-access, microprocessor-controlled clinical chemistry system. The modified device integrates a StreamLAB® Analytical Workcell and Sample Transfer Module to automate specimen preparation. The system processes human body fluid samples, performing automated pipetting, filtrate preparation, heating, and color intensity measurement to quantify analytes and enzyme activities. It also supports high-sensitivity chromium-based heterogeneous immunoassays via an HM module. Used in clinical laboratory environments by trained personnel, the system provides quantitative results that assist healthcare providers in diagnosing and monitoring patient health. The automation components streamline workflow by managing sample transport and preparation prior to analysis on the chemistry system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, operating principles, and performance characteristics identical to the predicate device.

Technological Characteristics

Discrete, random-access, microprocessor-controlled photometric chemistry analyzer. Includes integrated StreamLAB® Analytical Workcell and Sample Transfer Module for automated sample handling. Supports heterogeneous immunoassays via HM module. System is networked for laboratory automation. Sterilization and specific material standards are not detailed.

Indications for Use

Indicated for clinical use in laboratory settings to measure various analytes and enzyme activities in human body fluids via automated photometric analysis.

Regulatory Classification

Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Predicate Devices

• Dimension RxL Max™ (K043546)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K043546

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I device. The following items are present and acceptable (delete/add items as necessary) for the DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE:

1. The name and 510(k) number of DADE BEHRING, INC.'s previously cleared device, DIMENSION XL, cleared under K944093. (For a preamendments device, a statement to this effect has been provided.)
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.
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 connection of the StreamLab Analytical Workcell and Sample Transfer Module. The StreamLab is a front end specimen automation device that processes sample and transfers sample to the DIMENSION RXL MAX (family member to the family of Dimension Analyzers.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

4. 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
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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)

revised:3/27/98