DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)

K062162 · Dade Behring, Inc. · DKB · Sep 14, 2006 · Clinical Toxicology

Device Facts

• Record ID: K062162
• Device Name: DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
• Applicant: Dade Behring, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Sep 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines/Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC) methods on the Dimension Vista™ System. For prescription use only.

Device Story

UDAT CAL is a liquid, multi-analyte, human urine-based calibrator; consists of 6 vials (three Level A, three Level B). Used on Dade Behring Dimension Vista System; calibrates assays for Amphetamines, Barbiturates, Benzodiazepines, Cocaine metabolite, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene, and Cannabinoids. Level A contains 0 ng/mL; Level B contains specific concentrations of analytes. Intermediate levels are calculated by the instrument. Used in clinical toxicology settings by laboratory professionals. Provides reference points for instrument calibration to ensure accurate patient sample testing.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed 24-hour on-board stability (punctured), 31-day refrigerated stability (open), and 9-month closed-vial stability. Value assignment verified via gravimetric preparation, recovery testing, and GC/MS analysis.

Technological Characteristics

Liquid, multi-analyte, human urine-based calibrator. Traceable to USP reference materials or high-purity (99%) standards. Two-level kit (A and B). Automated intermediate level preparation via Dimension Vista System. Stability: 9 months shelf life; 24-hour on-board stability; 31-day open-vial stability.

Indications for Use

Indicated for the calibration of drugs of abuse assays (AMPH, BARB, BENZ, COC, METH, MTQ, OPI, PCP, PRX, THC) on the Dimension Vista System. For professional in vitro diagnostic use.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Syva® EMIT® Calibrators/Controls (K993755)

Submission Summary (Full Text)

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K062/62

SEP 1 4 2006

### 510(k) Summary for the Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

#### A. 510(k) Number:

| B. Analytes: | Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC). |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| C. Type of Test: | Calibrator Material |
| D. Applicant: | Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: [phone] Fax: [phone] |

#### E. Proprietary and Established Names:

Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

#### F. Regulatory Information:

- 1. Regulation section: 21 CFR § 862-1150 Calibrator
- 2. Classification: Class II
- 3. Product Code: DKB Calibrator, Drug Mixture
- 4. Panel: Toxicology
- G. Intended Use: The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTO), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC) methods on the Dimension Vista TM System.

### H. Device Description:

UDAT CAL is a liquid, multi-analyte, drug free human urine based product containing:

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

The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL for Calibrator A and 2.6 mL for Calibrator B. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

## I. Substantial Equivalence Information:

| | New Device | Predicate Device |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Dimension Vista™ System<br>Drugs of Abuse Calibrator | Syva® EMIT®<br>Calibrators/Controls<br>K993755 |
| Intended<br>Use | The UDAT CAL is an <i>in vitro</i> diagnostic<br>product for the calibration of<br>Amphetamines /Methamphetamines<br>(AMPH), Barbiturates (BARB),<br>Benzodiazepines (BENZ), Cocaine<br>Metabolite (COC), Methadone (METH),<br>Methaqualone (MTQ), Opiates (OPI),<br>Phencyclidine (PCP), Propoxyphene (PRX),<br>and Cannabinoids (THC) methods on the<br>Dimension Vista™ System. | The Emit® Calibrators/Controls are used in<br>the calibration of the Emit® II Plus<br>Amphetamines, Barbiturate,<br>Benzodiazepine, Cannabinoid, Cocaine<br>Metabolite, Ecstasy, Methadone,<br>Methaqualone, Monoclonal<br>Amphetamine/Methamphetamine, Opiates,<br>Phencyclidine, and Propoxyphene Assays. |
| Analytes | Amphetamines /Methamphetamines<br>(AMPH), Barbiturates (BARB),<br>Benzodiazepines (BENZ), Cocaine<br>Metabolite (COC), Methadone (METH),<br>Methaqualone (MTQ), Opiates (OPI),<br>Phencyclidine (PCP), Propoxyphene (PRX),<br>and Cannabinoids (THC). | Amphetamines, Barbiturate,<br>Benzodiazepine, Cannabinoid, Cocaine<br>Metabolite, Ecstasy, Methadone,<br>Methaqualone, Monoclonal<br>Amphetamine/Methamphetamine, Opiates,<br>Phencyclidine, and Propoxyphene. |
| Form | Liquid. | Liquid. |
| Traceability | USP1 for all analytes except:<br>BENZ - Benzodiazepine (99% purity)<br>(Cerilliant)2.<br>COC - Cocaine (99% purity) (Cerilliant).<br>THC - Cannabinoids (99% purity)<br>(Cerilliant). | USP for all analytes except:<br>BENZ - Benzodiazepine (99% purity)<br>(Cerilliant).<br>COC - Cocaine (99% purity) (Cerilliant).<br>THC - Cannabinoids (99% purity)<br>(Cerilliant). Standards. |
| Matrix | Human urine based. | Human urine based. |
| Number of<br>Levels | Two levels3. | Six levels. |

1 United States Pharmacopeia.

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2 Cerilliant Inc. 811 Paloma Drive, Suite A Roundrock, TX 78664

3 Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

#### J. Standard/Guidance Document Referenced:

- 1. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators: Final, 02/22/1999 Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004
- 2. Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices

### K. Performance Characteristics:

- 1. Stability: Target shelf life for the Dimension Vista™ System Drugs of Abuse Calibrator is nine months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20°C. The method is calibrated from this stored material. The 4℃ material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 10%. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc. A vial punctured by the instrument and stored on board is stable
for 24 hours. An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days.

For testing, vials are opened /punctured on day zero. For punctured vials, a quantity of calibrator sufficient for multiple calibrations is removed and the vials are recapped, punctured and stored at 2-8°C. Punctured vials are tested on Day 0. 1. 2. and 8 vs. freshly opened vials. For manually opened vials, half of the volume is removed and vials are recapped and tested on day 32 vs. freshly opened vials.

- The assigned values of the UDAT CAL are traceable to: 2. Traceability:

| Analyte | Constituent | Reference Material |
|----------------------------------|-------------------|------------------------------|
| Amphetamine /<br>Methamphetamine | D-methamphetamine | USP1 1429000; USP<br>1399001 |
| Barbiturate | Secobarbital | USP 1611004 |

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| Benzodiazepines | Lormetazepam | Benzodiazepine (99%<br>purity) (Cerilliant)2 |
|--------------------|-----------------------------------|----------------------------------------------|
| Cocaine Metabolite | Benzoylecgonine | Cocaine (99% purity)<br>(Cerilliant) |
| Methadone | Methadone | USP 1398009 |
| Opiates | Morphine | USP 1448005 |
| Phencyclidine | Phencyclidine | USP 1516003 |
| Cannabinoids | 11-nor- $\Delta$ 9-THC-9-<br>COOH | Cannabinoids (99%<br>purity) (Cerilliant) |
| Propoxyphene | Propoxyphene | USP 1404000 |
| Methylqualone | Methylqualone | USP 1575000 |

United States Pharmacopeia.

2 Cerilliant Inc. 811 Paloma Drive, Suite A Roundrock, TX 78664

- 3. Bottle Value Assignment:
D-Methamphetamine, Secobarbital, Lormetazepam, Benzovlecgonine. Methadone, Morphine, Phencyclidine. l 1-nor-A -THC-9-COOH, Propoxyphene, and Methylqualone Reference Material is weighed into drug free normal human urine at five levels and stored at -70° C. The verification of the Master Lot values are compared against previously approved Master Lot values and GC/MS' testing. The

approved Master Lot values were assigned with an instrument calibrated with the corresponding standard reference material.

The stock solution is made by adding D-Methamphetamine, Secobarbital, Lormetazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor-A-THC-9-COOH, Propoxyphene, and Methylqualone Reference Materials gravimetrically to stock solution at target concentrations and verified on an instrument calibrated with a previously approved Master Lot.

The commercial lot is made by adding calculated quantities of stock solution to drug free normal human urine in appropriate concentrations for each of the calibrator levels. The concentration of each level is verified using an instrument calibrated with Master Lot and GC/MS testing of each analyte in the Commercial lot. Values for each analyte are approved once the acceptable ranges for each analyte are met. The commercial lot is then filled, capped, labeled, and packaged.

¹ Gas Chromatography / Mass Spectrometry.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three bars extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

# SEP 1 4 2006

Mr. Victor Carrio Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

Re: K062162

> Trade/Device Name: Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: July 27, 2006 Received: July 28, 2006

Dear Mr. Carrio:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

### 510(k) Number (if known):

#### Device Name:

Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

# Indications for Use:

The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC) methods on the Dimension Vista™ System.

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KOG2162 510(k)