DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691

K081074 · Siemens Healthcare Diagnostics, Inc. · JLW · May 23, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081074
• Device Name: DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The TSHL method is an in vitro diagnostic test intended for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXLTM with LM system. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease. The TSH Sample Diluent is an in vitro diagnostic product for manual dilution of samples with elevated TSH results processed on the Dimension Vista® and Dimension® EXL™ with LM Systems.

Device Story

Dimension® TSHL Flex® reagent cartridge is an in vitro diagnostic device for quantitative TSH measurement in human serum/plasma. Used on Dimension® EXL™ with LM system. Employs LOCI® technology; utilizes liquid reagents and antibodies identical to predicate. TSH Sample Diluent (bovine serum albumin-based) allows manual dilution of high-concentration samples. Operated by laboratory personnel in clinical settings. Output provides TSH concentration values to clinicians for thyroid disease diagnosis and monitoring. Benefits include accurate, automated TSH quantification for clinical decision-making.

Clinical Evidence

Bench testing only. Precision and method comparison studies performed against automated laboratory analyzer. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

In vitro diagnostic reagent cartridge; LOCI® (Luminescent Oxygen Channeling Immunoassay) technology; bovine serum albumin-based diluent; 12 µL sample volume; liquid reagents; compatible with Dimension® EXL™ with LM system.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for the quantitative determination of TSH in human serum and plasma on the Dimension Vista system.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• Dimension Vista™ TSH Flex® reagent cartridge (K060090)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k081074

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.) Dimension Vista TSH Flex reagent cartridge, k060090

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 re-configuration of the reagent cartridge from a 12 wells cartridge to an 8 wells cartridge to be used on the Dimension EXL with LM system.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, analytes and performance characteristics. Studies include precision and method comparison with an automated laboratory analyzer.

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.