THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

K062128 · Dade Behring, Inc. · JHS · Aug 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062128
• Device Name: THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
• Applicant: Dade Behring, Inc.
• Product Code: JHS · Clinical Chemistry
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The CKMB method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB Isoenzyme in human serum and plasma on the Dimension Vista™ System. The HA1C assay used on the Dimension Vista™ System is an in vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c (HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus. The AMPH method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300. 500. or 1000 ne/mL on the Dimension Vista™ System. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The BARB method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of barbiturates in human urine on the Dimension Vista™ System. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The BENZ method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of benzodiazepines in human urine on the Dimension Vista™ System. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The Cocaine method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of benzoylecgonine in human urine on the Dimension Vista™ System. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose. The EXTC method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of methylenedioxymethamine (MDMA) and closely related drugs in human urine using a cutoff of 300 or 500 ng/mL on the Dimension Vista™ System. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The METH method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of methadone in human urine on the Dimension Vista™ System. Measurements obtained with the METH method are used to detect methadone use or overdose, and to determine compliance with methadone maintenance treatment. The OPI method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of opiates in human urine on the Dimension Vista™ System. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose. The PCP method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of phencyclidine in human urine on the Dimension Vista™ System. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The THC method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of cannabinoids in human urine on the Dimension Vista™ System. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose.

Device Story

Dimension Vista™ Flex® reagent cartridges and HA1C kit are prepackaged reagents for use on the Dimension Vista™ integrated system; a fully automated, microprocessor-controlled, floor-model clinical chemistry analyzer. System processes human serum, plasma, or urine samples to measure specific analytes. Reagents are identical to those used in previously cleared Dimension® clinical chemistry systems; packaging modified for Vista™ compatibility. Healthcare providers use quantitative or qualitative/semi-quantitative outputs to assist in diagnosing myocardial infarction, monitoring diabetes, or screening for drug use/overdose. Preliminary drug screen results require confirmatory testing. System automates sample handling, reagent delivery, and analysis, providing results to clinicians for diagnostic and treatment decision-making.

Clinical Evidence

Bench testing only; precision and method comparison studies conducted to validate performance of reagent packs on the new analyzer platform.

Technological Characteristics

Reagent packs for use with clinical chemistry analyzer. Modification involves platform compatibility. No changes to fundamental scientific technology.

Indications for Use

Indicated for quantitative measurement of CKMB in serum/plasma for diagnosis/treatment of myocardial infarction and muscle diseases; quantitative determination of HbA1c in anticoagulated whole blood for monitoring long-term glucose control in diabetics; qualitative/semi-quantitative screening of urine for amphetamines, barbiturates, benzodiazepines, cocaine metabolites, ecstasy (MDMA), methadone, opiates, phencyclidine, and cannabinoids for diagnosis/treatment of drug use or overdose. Preliminary results require confirmation via alternate chemical methods (e.g., GC/MS).

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter's Name: | Lorraine H Piestrak<br>Dade Behring Inc.<br>P.O. Box 6101<br>Newark, DE 19714-6101 | AUG 2 1 2006 |
|----------------------|------------------------------------------------------------------------------------|--------------|
| Date of Preparation: | July 25, 2006 | |

#### Name of Products:

Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge Dimension Vista™ Hemoglobin A1c Kit (HA1C) Dimension Vista™ Urine Amphetamine Screen (AMPH) Flex® reagent cartridge Dimension Vista™ Urine Barbiturates Screen (BARB) Flex® reagent cartridge Dimension Vista™ Urine Benzodiazepines Screen (BENZ) Flex® reagent cartridge Dimension Vista™ Urine Cocaine metabolite Screen (COC) Flex® reagent cartridge Dimension Vista™ Urine Ecstasy Screen (EXTC) Flex® reagent cartridge Dimension Vista™ Urine Methadone Screen (METH) Flex® reagent cartridge Dimension Vista™ Urine Opiates Screen (OPI) Flex® reagent cartridge Dimension Vista™ Urine Phencyclidine Screen (PCP) Flex® reagent cartridge Dimension Vista™ Urine Cannabinoids Screen (THC) Flex® reagent cartridge

### FDA Classification Name:

| Classification Name: | Common/Usual Name: |
|--------------------------------------------------------------|---------------------------------------|
| 862.1215 Differential Rate Kinetic Method, Cpk or Isoenzymes | Creatine kinase isoenzyme test system |
| 864.7470 Assay, Glycosylated Hemoglobin | Glycosylated hemoglobin test system |
| 862.3100 Enzyme Immunoassay, Amphetamine | Amphetamine test system |
| 862.3150 Enzyme Immunoassay, Barbiturate | Barbiturate test system |
| 862.3170 Enzyme Immunoassay, Benzodiazepine | Benzodiazepine test system |
| 862.3250 Enzyme Immunoassay, Cocaine and Metabolites | Cocaine and metabolite test system |
| 862.3100 Enzyme Immunoassay, Amphetamine | Ecstasy test system |
| 862.3620 Enzyme Immunoassay, Methadone | Methadone test system |
| 862.3650 Enzyme Immunoassay, Opiates | Opiate test system |
| 862.3100 Enzyme Immunoassay, Phencyclidine | Phencyclidine test system |
| 862.3870 Enzyme Immunoassay, Cannabinoids | Cannabinoid test system |

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### Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

| New Product | Predicate | Predicate<br>510(k) # | Device<br>class | Regulation | Product<br>Code |
|-----------------------------------------------------|--------------------------------------------|-----------------------|-----------------|------------|-----------------|
| Dimension Vista™<br>CKMB Flex®<br>reagent cartridge | Dimension® Flex®<br>CKMB reagent cartridge | K943024 | II | 862.1215 | JHS |
| Dimension Vista™<br>HA1C Kit | Dimension®<br>HA1C Kit | K011852 | II | 864.7470 | LCP |
| Dimension Vista™<br>AMPH Flex®<br>reagent cartridge | Dimension® Flex®<br>AMPH reagent cartridge | K040133 | II | 862.3100 | DKZ |
| Dimension Vista™<br>BARB Flex® reagent<br>cartridge | Dimension® Flex®<br>BARB reagent cartridge | K000459 | II | 862.3150 | DIS |
| Dimension Vista™<br>BENZ Flex® reagent<br>cartridge | Dimension® Flex®<br>BENZ reagent cartridge | K000458 | II | 862.3170 | JXM |
| Dimension Vista™<br>COC Flex® reagent<br>cartridge | Dimension® Flex®<br>COC reagent cartridge | K033713 | II | 862.3250 | DIO |
| Dimension Vista™<br>EXTC Flex® reagent<br>cartridge | Dimension® Flex®<br>EXTC reagent cartridge | K053337 | II | 862.3100 | DKZ |
| Dimension Vista™<br>METH Flex®<br>reagent cartridge | Dimension® Flex®<br>METH reagent cartridge | K000466 | II | 862.3620 | DJR |
| Dimension Vista™<br>OPI Flex® reagent<br>cartridge | Dimension® Flex®<br>OPI reagent cartridge | K003209 | II | 862.3650 | DJG |
| Dimension Vista™<br>PCP Flex® reagent<br>cartridge | Dimension® Flex®<br>PCP reagent cartridge | K000462 | II | 862.3100 | LCM |
| Dimension Vista™<br>THC Flex® reagent<br>cartridge | Dimension® Flex®<br>THC reagent cartridge | K000461 | II | 862.3870 | LDJ |

## Device Description:

Dade Behring Dimension Vista™ Flex® reagent cartridges and the HA1C kit are prepackaged Dude Delining Sincers on that are specifically designed to be used on the Dade m-viro diagnosio took model (asted system, a floor model, fully automated, microprocessor-Dontrolled, integrated instrument system. The Dimension Vista™ system was previously cleared

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with seven associated test methods (K051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The calibrator included in the Dimension Vista™ HAIC kit is the same product (unchanged) as that used in the Dimension® HA1C Kit. The packaging modification, does not affect the intended use of the devices. nor does it alter the fundamental scientific technology of the devices.

#### Intended Use:

#### Creatine Kinase MB Isoenzyme

The CKMB method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB Isoenzyme in human serum and plasma on the Dimension Vista™ System.

#### Hemoglobin A1c Kit

The HA1C assay used on the Dimension Vista™ System is an in vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c (HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus.

#### Urine Amphetamine/Methamphetamine Screen

The AMPH method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300. 500. or 1000 ne/mL on the Dimension Vista™ System. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.

#### Urine Barbiturates Screen

The BARB method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of barbiturates in human urine on the Dimension Vista™ System. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose.

### Urine Benzodiazepines Screen

The BENZ method is an in vitro diagnostic test for the qualitative and semi-quantitative determination of benzodiazepines in human urine on the Dimension Vista™ System. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.

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### Urine Cocaine metabolite Screen

The Cocaine method is an in vitro diagnostic test for the qualitative and semi-quantitative I he COC Methou is an in Thiro Chaghostic construction in human urine using a cutoff of 150 or delemmation of belizeyneegommo (60cm) System. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose.

### Urine Ecstasy Screen

The EXTC method is an in vitro diagnostic test for the qualitative and semi-quantitative I IIE EATC Inchiou is all in vir o diaglies betamine (MDMA) and closely related drugs in human urine using a cutoff of 300 or 500 ng/mL on the Dimension Vista™ System. Measurements urine using a cutorn of 500 or over in the diagnosis and treatment of ecstasy use or overdose.

### Urine Methadone Screen

The METH method is an in vitro diagnostic test for the qualitative and semi-quantitative I he MILTTT method is all in Viro diagnoine on the Dimension Vista™ System. Measurements determination of method are used to detect methadone use or overdose, and to determine compliance with methadone maintenance treatment.

### Urine Opiates Screen

The OPI method is an in vitro diagnostic test for the qualitative and semi-quantitative I he Oi i niculou is an in 'nive alagarine on the Dimension Vista™ System. Measurements decemmation of oplates in maintained in the diagnosis and treatment of opiates use or overdose.

### Urine Phencyclidine Screen

The PCP method is an in vitro diagnostic test for the qualitative and semi-quantitative I IC I CT nichlod is an in viro canghouse worke on the Dimension Vista™ System. Measurements determination of phenoyondation in names and treatment of phencyclidine use or overdose.

### Urine Cannabinoids Screen

The THC method is an in vitro diagnostic test for the qualitative and semi-quantitative I he 111c mediod is an in 71/7 o' diagnosurine on the Dimension Vista™ System. Measurements determination or cannaction the diagnosis and treatment of cannabinoids use or overdose.

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### Comparison to Predicate Device:

Compullion to 1 realert of Flex® reagent cartridges/kit and the predicate Dimension® Flex® Dour the Difficilision Visia - Pieres reagents in flexible plastic cartridges. A comparison of the reagult cartruges in contain propactials as reagues as as a cartridges is provided in the following table:

| Feature | Dimension Vista™<br>Flex® reagent cartridge | Dimension® Analyzer<br>Flex® reagent cartridge |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Reagents | Prepackaged, 12-well plastic, Dade<br>Behring Flex® reagent cartridges | Prepackaged, 6 & 8 well plastic, Dade<br>Behring Flex® reagent cartridges |
| Intended Use | <i>in vitro</i> diagnostic use | <i>in vitro</i> diagnostic use |
| Indications for Use | Same as Dimension® analyzer | As described in 510(k)s for each<br>previously cleared method. |
| Final concentration<br>of sample/reagent<br>ratio in test milieu | Same as Dimension® analyzer | As described in 510(k)s for each<br>previously cleared method |
| Tablet Sizes | 7/32" | 7/32" & 9/32" |
| Total tests contained<br>in each Flex®<br>cartridge | Approximately three times more<br>than contained in Dimension®<br>Flex® reagent cartridges | As described in 510(k)s for each<br>previously cleared method. |
| Calibration | 30 to 90 days<br>(determined for each method) | 30 to 90 days<br>As described in 510(k)s for each<br>previously cleared method. |
| HA1C calibrator | Same product as Dimension®<br>HA1C calibrator | As described in K011852 |

## Comments on Substantial Equivalence:

The Dade Behring Dimension Vista™ Flex® reagent cartridges and the Dimension® Flex® The Dado Bolling Dimensioned similarly for the same purpose. Both contain prepackaged reagents for in-vitro diagnostic tests that are processed on microprocessor-controlled, integrated instrument systems to analyze a variety of analytes in human specimens.

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The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those The reagents connamed in the Damelible manufactured for the Dimension® clinical chemistry comained in the Frex® reagone cartring analyzers. The calibrator included in the Dimension Vista™ Systems, another railing of the same product (unchanged) as that used in the Dimension® HA1C Kit. The packaging modifications do not affect the intended use of the devices, nor do they alter the fundamental scientific technology of the devices.

Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance.

#### Conclusion:

Conclusion:
The Flex® reagent cartridges/kit, containing reagents for testing CKMB, HA1C, AMPH, BARB, THE FIEA® FEAGERE Canning Concenting Concension® Vista™ Integrated system are DENZ, COC, LATC, METTI, OF I, I OF , Les , Lean performance to the Dimension® system Flex® Substantially equivalent in abongs, for same intended use and indications for use. Comparative testing also demonstrates substantially equivalent performance.

Louise H. Prestvik

Lorraine H Piestrak Regulatory Affairs & Compliance Manager July 25, 2006

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract representation of a human figure.

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine Piestrak Regulatory Affairs & Compliance Manager Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101

AUG 2 1 2006

Re: k062128

> Trade/Device Name: Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge Dimension Vista™ Hemoglobin A1c Kit (HA1C) Dimension Vista™ Urine Amphetamine/Methamphetamine Screen (AMPH)Flex® reagent cartridge Dimension Vista™ Urine Barbiturates Screen (BARB) Flex® reagent cartridge Dimension Vista™ Urine Benzodiazepines Screen (BENZ) Flex® reagent cartridge Dimension Vista™ Urine Cocaine metabolite Screen (COC) Flex® reagent cartridge Dimension Vista™ Urine Ecstasy Screen (EXTC) Flex® reagent cartridge Dimension Vista™ Urine Methadone Screen (METH) Flex® reagent cartridge Dimension Vista™ Urine Opiates Screen (OPI) Flex® reagent cartridge Dimension Vista™ Urine Phencyclidine Screen (PCP) Flex® reagent cartridge Dimension Vista™ Urine Cannabinoids Screen (THC) Flex® reagent cartridge Regulation Number: 21 CFR\$862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHS, LCP, DKZ, DIS, JXM, DIO, DJR, DJG, LCM, LDJ Dated: July 25, 2006 Received: July 26, 2006

Dear Ms. Piestrak:

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.

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#### Page 2 - Ms. Lorraine Piestrak

,

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).

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/cdrl/industry/support/

Sincerely yours,

Alberto
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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510(k) Number (if known): K06212

K062128

Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® Device Name: reagent cartridge

Indications For Use:

The Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a r no Difficial of Your - See the activity of the creatine kinase MB isoenzyme in plasma and de vice intendou to measurement with isoenzyme are used in the diagnosis and treatment Scrum: "Infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

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

Over-The-Counter Use (21 CFR 801)

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

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

Page 1 of ||

Division Sign-Off

Division Sign-Off

510(k) K062128

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< 062128 510(k) Number (if known):

Dimension Vista™ Hemoglobin A1c Kit (HA1C) Device Name:

Indications For Use:

The HAIC assay used on the Dimension Vista™ integrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c(HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

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

Over-The-Counter Use (21 CFR 801)

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

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

Page ) of li

Division Sign-Off

KOi 2128

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< 062128 510(k) Number (if known):

Device Name: Dimension Vista™ Urine Amphetamine/Methamphetamine Screen (AMPH) Flex® reagent cartridge

Indications For Use:

The AMPH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose.

The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

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

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

C. Taylor

Page 3 of 11

Division Sign/Off

KOC 2128

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002128 510(k) Number (if known):

Device Name: Dimension Vista™ Urine Barbiturates Screen (BARB) Flex® reagent cartridge

Indications For Use:

The BARB Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of barbiturates in human urine. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose.

The BARB method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Over-The-Counter Use (21 CFR 801)

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

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

Division Sign-Off

Page of 11

062128

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510(k) Number (if known): < Olo 2128

Dimension Vista™ Urine Benzodiazepines Screen (BENZ) Flex® Device Name: reagent cartridge

Indications For Use:

The BENZ Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzodiazepines in human urine. Measurements obtained . with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose.

The BENZ method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Over-The-Counter Use (21 CFR 801)

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

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

GTC

Page of 11

Jivision Sign-Off

K062128

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06200 510(k) Number (if known):

Dimension Vista™ Urine Cocaine metabolite Screen (COC) Flex® Device Name: reagent cartridge

#### Indications For Use:

The COC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose.

The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use X · (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

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

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

CAC

Division Sign-Off

Page of II

062128

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ﭗ ﮨ k 062128 510(k) Number (if known):

Dimension VistaTM Urine Ecstasy Screen (EXTC) Flex® reagent Device Name: cartridge

Indications For Use:

The EXTC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamine (MDMA), and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose.

The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Over-The-Counter Use (21 CFR 801)

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

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

Ote

Jusion Sign-Off

Page 7 of 11

K062128

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510(k) Number (if known): KO6 2129

Dimension Vista™ Urine Methadone Screen (METH) Flex® reagent Device Name: cartridge

Indications For Use:

The METH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methadone in human urine. Measurements obtained with the METH method are used to detect methadone use or overdose and to determine compliance with methadone maintenance treatment.

The METH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Over-The-Counter Use (21 CFR 801)

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

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

G.C.

*Author Signature OR*

Page Bof 11

c 2128

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KO62128 510(k) Number (if known):

Dimension Vista™ Urine Opiates Screen (OPI) Flex® reagent Device Name: cartridge

Indications For Use:

The OPI Flex® reagent cartridge (300 ng/mL cutoff) used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of opiates in human urine. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose.

The OPI method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

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2062124 510(k) Number (if known):

Dimension Vista™ Urine Phencyclidine Screen (PCP) Flex® reagent Device Name: cartridge

Indications For Use:

The PCP Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.

The PCP method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

Over-The-Counter Use (21 CFR 801)

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

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510(k) Number (if known):

1062121

Dimension Vista™ Urine Cannabinoids Screen (THC) Flex® reagent Device Name: cartridge

Indications For Use:

The THC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of cannabinoids in human urine. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose.

The THC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801)

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

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

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