K Number

Device Name

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

Manufacturer

DADE BEHRING, INC.

Date Cleared

2006-09-14

(48 days)

Product Code

DKB

Regulation Number

862.3200

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.

Device Description

UDAT CAL is a liquid, multi-analyte, drug free human urine based product containing: D-methamphetamine, Secobarbital, Lormetazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor- $\Delta$ 9-THC-9-COOH, Propoxyphene, and 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K993755

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition and stability of a calibration product for a diagnostic system. There is no mention of AI or ML in the provided text. The calculation of intermediate levels by the Dimension Vista™ System is described as an automatic process, which does not necessarily imply the use of AI/ML.

Therapeutic

The device is an in vitro diagnostic product used for the calibration of methods for detecting various drugs of abuse, not for directly treating a medical condition.

Diagnostic

Explanation: The device is described as an "in vitro diagnostic product for the calibration" of methods used to detect various substances. It is a calibrator, not a diagnostic device itself.

SaMD (Software as a Medical Device)

The device description clearly states it is a liquid, multi-analyte, drug-free human urine-based product consisting of vials containing specific chemical substances. This is a physical product, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the UDAT CAL is an "in vitro diagnostic product".
Function: The device is used for the calibration of methods that detect specific substances (drugs of abuse) in a human sample (urine). This is a core function of many in vitro diagnostic devices.
Sample Type: The device is used with human urine, which is a biological sample.
Context: The device is intended for use on the Dimension Vista™ System, which is a laboratory instrument typically used for in vitro diagnostic testing.

The description clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DKB

Device Description

UDAT CAL is a liquid, multi-analyte, drug free human urine based product containing:
Analyte, Constituent
Amphetamine/Methamphetamine, D-methamphetamine
Barbiturate, Secobarbital
Benzodiazepines, Lormetazepam
Cocaine Metabolite, Benzoylecgonine
Methadone, Methadone
Opiates, Morphine
Phencyclidine, Phencyclidine
Cannabinoids, 11-nor-$\Delta$9-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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Traceability: The assigned values of the UDAT CAL are traceable to:
Analyte, Constituent, Reference Material
Amphetamine /Methamphetamine, D-methamphetamine, USP1 1429000; USP 1399001
Barbiturate, Secobarbital, USP 1611004
Benzodiazepines, Lormetazepam, Benzodiazepine (99% purity) (Cerilliant)2
Cocaine Metabolite, Benzoylecgonine, Cocaine (99% purity) (Cerilliant)
Methadone, Methadone, USP 1398009
Opiates, Morphine, USP 1448005
Phencyclidine, Phencyclidine, USP 1516003
Cannabinoids, 11-nor-Δ9-THC-9-COOH, Cannabinoids (99% purity) (Cerilliant)
Propoxyphene, Propoxyphene, USP 1404000
Methylqualone, Methylqualone, USP 1575000
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K993755

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
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.)(b)
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.

Summary

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: (302) 631-0376 Fax: (302) 631-6299

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
1. Classification: Class II
1. Product Code: DKB Calibrator, Drug Mixture
1. 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:

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

I. Substantial Equivalence Information:

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

1 United States Pharmacopeia.

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
1. 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.

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

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

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

United States Pharmacopeia.

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

1. 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.

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).

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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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

Indications For Use Statement

510(k) Number (if known):

Device Name:

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

Indications for Use:

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)