DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

K062191 · Dade Behring, Inc. · DIF · Aug 21, 2006 · Clinical Toxicology

Device Facts

• Record ID: K062191
• Device Name: DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
• Applicant: Dade Behring, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The Dimension Vista™ System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System. The Dimension Vista™ System Drugs of Abuse Negative Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.

Device Story

Liquid, human urine-based quality control materials; used to monitor performance of drugs of abuse assays on Dimension Vista System. Positive control contains analytes above assay cutoff; negative control contains analytes below cutoff. Ready-to-use vials; no preparation required. Healthcare providers use these controls to verify assay accuracy and precision during routine clinical toxicology testing. Values assigned via GC/MS reference testing.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed via GC/MS reference testing; stability protocols and acceptance criteria were evaluated and found acceptable.

Technological Characteristics

Liquid, human urine-based multi-analyte control. Constituents: D-methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor-Δ⁹-THC-9-COOH. Traceable to GC/MS reference testing. Designed for use on Dimension Vista System.

Indications for Use

Indicated for use as quality control material for drugs of abuse testing (AMPH, BARB, BENZ, COC, METH, OPI, PCP, THC) on the Dimension Vista System. For prescription use.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Dimension® Drugs of Abuse Positive Control (k950138)
• Dimension® Drugs of Abuse Negative Control (k950138)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k062191

B. Purpose for Submission:
510(k) premarket notification package to manufacture and market the Dimension Vista™ System Drugs of Abuse Positive Control (UDAT CON(+)-KC515) and Negative Control (UDAT CON(-)-KC516).

C. Measurand:
Control Materials for Amphetamine/Methamphetamine, Barbiturate, Benzodiazepines, Cocaine Metabolite, Methadone, Opiates, Phencyclidine, and Cannabinoids.

D. Type of Test:
Control Materials

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista™ Drugs of Abuse Positive Control
Dimension Vista™ Drugs of Abuse Negative Control

G. Regulatory Information:
1. Regulation section:
862.3280 - Clinical toxicology control material
2. Classification:
Class I
3. Product code:

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Drug mixture control materials (DIF)

4. Panel:

Toxicology (91)

# H. Intended Use:

1. Intended use(s):

See Indication(s) for use below.

2. Indication(s) for use:

The Dimension Vista™ System Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.

The Dimension Vista™ System Drugs of Abuse Negative Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension Vista™ System.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

Dimension Vista System

# I. Device Description:

The Dimension Vista™ System Drugs of Abuse Positive Control is a liquid, multi-analyte, human urine-based product for the following constituents at above the cutoff levels of the methods:

| Analyte | Constituent |
| --- | --- |
| Amphetamine/Methamphetamine | D-methamphetamine |
| Barbiturate | Secobarbital |
| Benzodiazepines | Nordiazepam |
| Cocaine Metabolite | Benzoylecgonine |
| Methadone | Methadone |

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3

| Analyte | Constituent |
| --- | --- |
| Opiates | Morphine |
| Phencyclidine | Phencyclidine |
| Cannabinoids | 11-nor-Δ⁹-THC-9 –COOH |

The kit consists of six vials which are ready for use (no preparation is required). The volume per vial is 2.5 mL.

The Dimension Vista™ System Drugs of Abuse Negative Control is a liquid, multi-analyte, human urine-based product containing the following constituents below the cutoff levels of the methods:

| Analyte | Constituent |
| --- | --- |
| Amphetamine/Methamphetamine | D-methamphetamine |
| Barbiturate | Secobarbital |
| Benzodiazepines | Nordiazepam |
| Cocaine Metabolite | Benzoylecgonine |
| Methadone | Methadone |
| Opiates | Morphine |
| Phencyclidine | Phencyclidine |
| Cannabinoids | 11-nor-Δ⁹-THC-9 –COOH |

The kit consists of six vials which are ready for use (no preparation is required). The volume per vial is 2.5 mL

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension® Drugs of Abuse Positive Control

Dimension® Drugs of Abuse Negative Control

2. Predicate 510(k) number(s):

k950138

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Amphetamines /Methamphetamines (AMPH), Barbiturates | Amphetamines /Methamphetamines (AMPH), Barbiturates |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC). | (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC). |
| Form | Liquid | Liquid |
| Traceability | GC/MS | GC/MS |
| Matrix | Human urine based | Human urine based |
| Number of levels | One positive, one negative | One positive, one negative |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | The Dimension Vista™ System Drugs of Abuse Control is an in vitro diagnostic product intended as quality control product for the Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC) methods on the Dimension VistaTM System. | The Drugs of Abuse Positive Control is an in vitro diagnostic product intended as quality control product for the following methods packaged in Flex® reagent cartridges: Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC). |

# K. Standard/Guidance Document Referenced (if applicable):

FDA Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final

FDA Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

FDA Guidance for Industry - Points to Consider Guidance Document on

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Assayed and Unassayed Quality Control Material

FDA Guidance for Industry and FDA Staff – Bundling Multiple Devices or Multiple Indications in a Single Submission; Draft

CEN 13640 Stability testing of In-Vitro Diagnostic Devices

ISO 14971:2000 Medical devices - Application of risk management to medical devices

L. Test Principle:

Not Applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: Not Applicable
b. Linearity/assay reportable range: Not Applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability

The assigned values of the Dimension Vista™ System Drugs of Abuse Positive Control and the Dimension Vista™ System Drugs of Abuse Negative Control are traceable to Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing.

Value Assignment

Calculated quantities of D-Methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, and 11-nor-Δ⁹-THC-9-COOH high purity stock solutions are added to drug free normal human urine to target concentrations for each of the Negative and Positive Controls. The Negative and Positive Bulk Products are tested by GC/MS and any analyte that is out of the acceptable GC/MS range is adjusted and retested. Values are assigned to the controls once the GC/MS results are in the acceptable ranges.

Stability

Protocols and acceptance criteria were described and found to be acceptable.

d. Detection limit:

5

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Not Applicable

e. Analytical specificity:
Not Applicable

f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.