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 Description

The Dimension Vista™ System Drugs of Abuse Positive Control is a liquid, multi-analyte, human urine-based product containing the following constituents at above the cutoff levels of the methods: D-methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, and 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: D-methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, and 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.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the Dimension Vista™ System Drugs of Abuse Positive Control (UDAT CONT (+) - KC515) and the Dimension Vista™ System Drugs of Abuse Negative Control (UDAT CONT (-) - KC516). These are quality control products, not a diagnostic device for direct patient diagnosis, so the performance criteria and study details are focused on the stability and traceability of the control materials themselves.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a control material, the performance criteria are related to its stability and traceability. The "reported device performance" is essentially that the device met these stability and traceability requirements.

Acceptance Criteria (Target/Method)	Reported Device Performance
Shelf-Life Stability: Percent change over time for controls stored at 4°C vs. -20°C (Calibrated from -20°C material, 4°C material values recovered against calibration).	Shelf-life stability (expiration) dating assignment at commercialization reflects real-time data on file. The document states a target shelf life of twelve months and indicates that percent change is "than or equal to 10%", implying this was the acceptance threshold met.
On-Board Stability (Punctured Vial on Instrument): Control stable for this duration.	Stable for seven days.
Open Vial Stability (Recapped, Refrigerated, Not on Instrument): Control stable for this duration.	Stable for 31 days.
Traceability: Assigned values for Negative and Positive Controls.	Traceable to Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing. Values are assigned to controls once GC/MS results are in acceptable ranges. This implies the GC/MS results confirmed the expected concentrations, meeting the traceability acceptance.
Bottle Value Assignment: Bulk products tested by GC/MS.	Values are assigned to the controls once the GC/MS results are in the acceptable ranges. This implicitly states that the GC/MS testing confirmed the concentrations and that these results were within the established acceptable range for the controls. Calculated quantities of constituents were added to achieve target concentrations, and GC/MS confirmed these.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set sample size" in terms of number of unique subjects or samples. Instead, the stability studies involve testing vials of the control material at specific time points. For the punctured vial stability, "multiple tests" are performed, and vials are tested on Day 8, 15, 22, and 32. The number of vials or replicates used for each time point is not specified.
Data Provenance: The human urine used as the matrix is mentioned, implying human origin. The studies appear to be prospective as they involve real-time stability testing over a period (e.g., 12 months for shelf-life, 7 days for on-board, 31 days for open vial). The location of the studies is implicitly at Dade Behring Inc. in Newark, DE, USA, as they are the applicant and manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of these control materials. "Ground truth" for diagnostic devices typically refers to a definitive diagnosis or condition established by clinical experts or gold standard methods. For control materials, the "ground truth" for the concentration of the analytes is established by Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing, which is a highly precise analytical technique, not by human expert interpretation in the traditional sense. The expertise lies in operating and interpreting GC/MS results.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" involves analytical measurements against established chemical standards (GC/MS), not subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. The device is a quality control material, not an AI-powered diagnostic device. No human reader studies, AI assistance, or MRMC studies were performed or are relevant for this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a chemical control material. There is no algorithm involved in its primary function, nor is it standalone in the context of AI performance. Its function is to verify the performance of an analytical instrument (Dimension Vista™ System).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the individual analyte concentrations within the control materials is established through Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing. This is a highly accurate and precise analytical method considered a gold standard for quantifying these substances. The document explicitly states: "The assigned values... are traceable to Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing."

8. The Sample Size for the Training Set

This information is not applicable. This is a quality control product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of product.

Summary

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510(k) Summary for the Dimension Vista™ System Drugs of Abuse Positive Control (UDAT CONT (+) - KC515) and Dimension Vista™ System Drugs of Abuse Negative Control (UDAT CONT (-) - KC516)

Kob2191 A. 510(k) Number:

Amphetamines /Methamphetamines (AMPH), Barbiturates B. Analytes: (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Opiates (OPI), Phencyclidine (PCP), and Cannabinoids (THC).
C. Type of Test: Drugs of Abuse Controls
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 Positive Control (UDAT CON (+) - KC515) Dimension Vista™ System Drugs of Abuse Negative Control (UDAT CON (-) - KC516)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862 3280 Clinical toxicology control material
1. Classification: Class I
1. Product Code: DIF Drug Mixture Control Material
1. Panel: Toxicology
G. Intended 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.

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H. Device Description:

The Dimension Vista™ System Drugs of Abuse Positive Control is a liquid, multi-analyte, human urine-based product containing 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
Opiates	Morphine
Phencyclidine	Phencyclidine
Cannabinoids	11-nor- $\Delta$ 9-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.

I. Substantial Equivalence Information:

The Dimension Vista™ System Drugs of Abuse Positive Control and the Dimension Vista™ System Drugs of Abuse Negative Control are substantially equivalent to the Dimension® Drugs of

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Abuse Positive Control (DC43A) and the Dimension® Drugs of Abuse Negative Control (DC44A), both products cleared under K950138. The following table summarizes product similarities and differences:

	New Device	Predicate Device
Item	Dimension Vista™ SystemDrugs of Abuse Positive Control	Dimension® Drugs of AbusePositive Control (DC43A)K950138
IntendedUse	The Dimension Vista™ System Drugs ofAbuse Control is an in vitro diagnosticproduct intended as quality control productfor the Amphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Opiates (OPI), Phencyclidine (PCP), andCannabinoids (THC) methods on theDimension Vista™ System.	The Drugs of Abuse Positive Control is anin vitro diagnostic product intended asquality control product for the followingmethods packaged in Flex® reagentcartridges: Amphetamines/Methamphetamines (AMPH), Barbiturates(BARB), Benzodiazepines (BENZ),Cocaine Metabolite (COC), Methadone(METH), Opiates (OPI), Phencyclidine(PCP), and Cannabinoids (THC).
Analytes	Amphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Opiates (OPI), Phencyclidine (PCP), andCannabinoids (THC).	Amphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Opiates (OPI), Phencyclidine (PCP), andCannabinoids (THC).
Form	Liquid.	Liquid.
Traceability	GC/MS1.	GC/MS.
Matrix	Human urine based.	Human urine based.
Number ofLevels	One Level.	One level.

Gas Chromatography / Mass Spectrometry.

	New Device	Predicate Device
Item	Dimension Vista™ SystemDrugs of Abuse Negative Control	Dimension® Drugs of AbuseNegative Control (DC44A)K950138
IntendedUse	The Dimension Vista™ System Drugs ofAbuse Control is an in vitro diagnosticproduct intended as quality control productfor the Amphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Opiates (OPI), Phencyclidine (PCP), andCannabinoids (THC) methods on theDimension Vista™ System.	The Drugs of Abuse Positive Control is anin vitro diagnostic product intended asquality control product for the followingmethods packaged in Flex® reagentcartridges: Amphetamines/Methamphetamines (AMPH), Barbiturates(BARB), Benzodiazepines (BENZ),Cocaine Metabolite (COC), Methadone(METH), Opiates (OPI), Phencyclidine(PCP), and Cannabinoids (THC).
Analytes	Amphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Opiates (OPI), Phencyclidine (PCP), and	Amphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Opiates (OPI), Phencyclidine (PCP), and

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	Cannabinoids (THC).	Cannabinoids (THC).
Form	Liquid.	Liquid.
Traceability	GC/MS'.	GC/MS
Matrix	Human urine based.	Human urine based.
Number ofLevels	One level.	One level.

Gas Chromatography / Mass Spectrometry.

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 Guidance for Industry - Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material Guidance for Industry and FDA Staff - Bundling Multiple Devices or Multiple Indications in a Single Submission
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 both the Dimension Vista™ System Drugs of Abuse Positive Control and the Dimension Vista™ System Drugs of Abuse Negative Control is twelve months. Control shelf life is determined by comparing results of the product stored at 4°C with control stored at -20°C. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change is 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 seven days. 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 sufficient for multiple tests is removed and the vials are recapped, punctured and stored at 2-8°C. Punctured vials are tested on Day 8, 15, 22, and 32 vs. freshly opened vials.

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The assigned values of the Dimension Vista™ System Drugs of 2. Traceability: Abuse Positive Control and the Dimension Vista™ System Drugs of Abuse Negative Control are traceable to Gas Chromatography / Mass Spectrometry (GC/MS) Reference Testing.
1. Bottle Value Assignment:

Calculated quantities of D-Methamphetamine, Secobarbital, Nordiazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, and 11-nor-A2-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'. Values are assigned to the controls once the GC/MS results are in the acceptable ranges.

1 Gas Chromatography / Mass Spectrometry

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor M. Carrio RA/OS Compliance Manager Dade Behring. Inc. Mailstop 514 500 GBC Drive Newark, DE 19714-6101

AUG 2 1 2006

Re: K062191

Trade/Device Name: Dimension Vista™ System Drugs of Abuse Positive Control (UDAT CON (+) - KC515) Dimension Vista™ System Drugs of Abuse Negative Control (UDAT CON (-) -KC516) Regulation Number: 21 CFR §862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: Class I Product Code: DIF Dated: July 27, 2006 Received: July 31, 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 (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, Ph.D.

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 Positive Control (UDAT CON (+) - KC515) Dimension Vista™ System Drugs of Abuse Negative Control (UDAT CON (-) - KC516)

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)

Carl P.C. Binen
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 062191

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
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.(b)
Classification. Class I (general 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.