DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE

K062024 · Dade Behring, Inc. · LFM · Jul 28, 2006 · Clinical Toxicology

Device Facts

• Record ID: K062024
• Device Name: DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
• Applicant: Dade Behring, Inc.
• Product Code: LFM · Clinical Toxicology
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3300
• Device Class: Class 2

Indications for Use

The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy. The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy. The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy. The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

Device Story

The device consists of Dimension Flex reagent cartridges for Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, and Theophylline. The modification involves repackaging these existing reagents for use on the Dimension Vista platform. The modification increases the number of tests per reagent pack by proportionally decreasing reagent and sample volumes while maintaining the same final sample/reagent concentration ratio in the test milieu. The device is used in clinical laboratory settings to perform diagnostic assays. The modification was validated through Failure Mode and Effect Analysis (FEMA) and verification of test performance to ensure no loss of precision or accuracy compared to the predicate Dimension platform reagents.

Clinical Evidence

Bench testing only. The sponsor performed a risk analysis (FMEA) and verification activities to confirm that the reduction in reagent and sample volumes maintained the same final concentration ratio as the predicate devices, ensuring equivalent performance.

Technological Characteristics

Reagent cartridges for clinical chemistry assays. Modification involves proportional reduction of reagent and sample volumes to increase tests per pack. Fundamental scientific technology remains consistent with previously cleared Dimension Flex reagent cartridges. No changes to detection methods or analytes.

Indications for Use

Indicated for quantitative measurement of digitoxin, digoxin, gentamicin, N-acetylprocainamide, phenytoin, or theophylline in human serum and plasma for therapeutic drug monitoring and overdose diagnosis. Prescription use only.

Regulatory Classification

Identification

A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

Predicate Devices

• Dimension® DGTX Flex® reagent cartridge (K990251)
• Dimension® DGNA Flex® reagent cartridge (K946153)
• Dimension® GENT Flex® reagent cartridge (K962819)
• Dimension® NAPA Flex® reagent cartridge (K032564)
• Dimension® PTN Flex® reagent cartridge (K911056)
• Dimension® THEO Flex® reagent cartridge (K862955)

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 k062024

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 :

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
k990251 – Dimension Digitoxin Flex reagent cartridge
k946153 – Dimension Digoxin Flex reagent cartridge
k962819 – Dimension Gentamicin Flex reagent cartridge
k032564 – Dimension N-acetylprocainamide Flex reagent cartridge
k911056 – Dimension Phenytoin Flex reagent cartridge
k862955 – Dimension Theophylline Flex reagent cartridge

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 repackaging existing reagents.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, sample type, analytes, detection methods and the number of tests per reagent pack. The Dimension Vista supports more tests per pack than the Dimension platform. This was accomplished by decreasing the reagent and sample volumes.

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.

The sponsor conducted a Failure Mode and Effect Analysis (FEMA); this analysis did not identify any risks. An internal review identified the loss of precision due to a decrease in reagent volume and pipetting errors as the primary risks associated with this platform migration.

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

A comparison of the new device and predicate labeling indicates the reduction in reagent volume is proportionate to the reduction in sample volume. The final concentration of sample/reagent ratio in the test milieu is the same for the both devices.

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.

5. 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

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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 device.

07/24/06
(Date)
(Reviewer's Signature)
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revised:8/1/03