K Number

Device Name

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

Manufacturer

DADE BEHRING, INC.

Date Cleared

2006-08-21

(21 days)

Product Code

DIF

Regulation Number

862.3280

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. 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.

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

K950138

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a quality control product for drug testing, which is a chemical reagent and does not involve data processing or algorithmic analysis.

Therapeutic

No
The device is described as an "in vitro diagnostic product intended as quality control product" for methods on the Dimension Vista™ System. It is used to test for drugs of abuse and does not provide therapeutic treatment.

Diagnostic

The device is described as an "in vitro diagnostic product intended as quality control product" for drug testing methods. Quality control products are used to verify the performance of a diagnostic device, but they are not themselves diagnostic devices because they do not directly diagnose a condition in a patient.

SaMD (Software as a Medical Device)

The device is described as a liquid, multi-analyte, human urine-based product in vials, which are physical components, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The document explicitly states that the products are "in vitro diagnostic product intended as quality control product" for specific drug testing methods on the Dimension Vista™ System. This clearly indicates their use in a laboratory setting to evaluate the performance of diagnostic tests.
Device Description: The description details the composition of the controls (human urine-based with specific drug constituents) and their format (liquid, ready for use vials). This aligns with the typical description of IVD control materials.
Intended User/Care Setting: The "Prescription Use" designation further supports its use in a clinical or laboratory setting under the direction of a healthcare professional.
Predicate Device(s): The mention of predicate devices with K numbers (K950138) indicates that these products have gone through the regulatory process for medical devices, specifically IVDs.

While the document doesn't contain information about image processing, AI, or patient demographics, the core information provided strongly identifies these products as IVDs used for quality control in drug testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DIF

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:
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.

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:
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.

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

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.
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.
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.

Key Metrics

Not Found

Predicate Device(s)

K950138

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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.

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

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™ System
Drugs of Abuse Positive Control	Dimension® Drugs of Abuse
Positive Control (DC43A)
K950138
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 Vista™ 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).
Analytes	Amphetamines /Methamphetamines
(AMPH), Barbiturates (BARB),
Benzodiazepines (BENZ), Cocaine
Metabolite (COC), Methadone (METH),
Opiates (OPI), Phencyclidine (PCP), and
Cannabinoids (THC).	Amphetamines /Methamphetamines
(AMPH), Barbiturates (BARB),
Benzodiazepines (BENZ), Cocaine
Metabolite (COC), Methadone (METH),
Opiates (OPI), Phencyclidine (PCP), and
Cannabinoids (THC).
Form	Liquid.	Liquid.
Traceability	GC/MS1.	GC/MS.
Matrix	Human urine based.	Human urine based.
Number of
Levels	One Level.	One level.

Gas Chromatography / Mass Spectrometry.

	New Device	Predicate Device
Item	Dimension Vista™ System
Drugs of Abuse Negative Control	Dimension® Drugs of Abuse
Negative Control (DC44A)
K950138
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 Vista™ 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).
Analytes	Amphetamines /Methamphetamines
(AMPH), Barbiturates (BARB),
Benzodiazepines (BENZ), Cocaine
Metabolite (COC), Methadone (METH),
Opiates (OPI), Phencyclidine (PCP), and	Amphetamines /Methamphetamines
(AMPH), Barbiturates (BARB),
Benzodiazepines (BENZ), Cocaine
Metabolite (COC), Methadone (METH),
Opiates (OPI), Phencyclidine (PCP), and

	Cannabinoids (THC).	Cannabinoids (THC).
Form	Liquid.	Liquid.
Traceability	GC/MS'.	GC/MS
Matrix	Human urine based.	Human urine based.
Number of
Levels	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.

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

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).

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

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