DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR

K060628 · Dade Behring, Inc. · CIG · Apr 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060628
• Device Name: DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
• Applicant: Dade Behring, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Apr 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Indications for Use

TBI Flex® reagent cartridge: The TBI method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease. DBI Flex® reagent cartridge: The DBI method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure direct bilirubin in human serum and plasma. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disease. TBI/DBI Calibrator: The Dimension® Bilirubin Calibrator is an in vitro diagnostic product intended to be used to calibrate the Direct Bilirubin (DBI) and Total Bilirubin (TBI) methods for the Dimension® clinical chemistry system. This product was designed to meet the needs of users to assure accurate results over the assay range of these methods.

Device Story

TBI and DBI Flex® reagent cartridges are in vitro diagnostic assays for the Dimension® clinical chemistry system. Input: human serum or plasma samples. Principle: photometric diazo chemistry. TBI assay solubilizes bilirubin using caffeine/benzoate/acetate/EDTA; DBI assay uses 0.5M HCl. Both convert bilirubin to a red diazo-bilirubin chromophore. Output: absorbance measured via bichromatic (540, 700 nm) endpoint technique. Used in clinical laboratories by technicians/pathologists. Results assist clinicians in diagnosing/treating liver, hemolytic, hematological, and metabolic disorders. Calibrator uses purified water (level 0) and ditauro-bilirubin (levels 1-3) to ensure assay accuracy.

Clinical Evidence

Bench testing only; design control activities including risk analysis and verification/validation performed to confirm modifications meet predetermined acceptance criteria.

Technological Characteristics

Reagent cartridges and calibrators for clinical chemistry analysis. Modifications involve fluidic/volume parameters and hemoglobin interference correction logic. Fundamental scientific technology unchanged.

Indications for Use

Indicated for quantitative measurement of total and direct bilirubin in human serum and plasma to aid in diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders (e.g., hepatitis, gallbladder disease).

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Predicate Devices

• k861700
• k862359

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 k060628

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.) k861700, k862359, k861700
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:

TBI Flex® reagent cartridge, DBI Flex® reagent cartridge, and TBI/DBI Bilirubin Calibrator. Changes were made to volume of the sample required, hemoglobin correction levels, hemoglobin correction flags and the volume of cartridge.

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

revised:8/1/03