VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV

K063164 · Ortho-Clinical Diagnostics, Inc. · LDJ · Dec 28, 2006 · Clinical Toxicology

Device Facts

• Record ID: K063164
• Device Name: VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Dec 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

VITROS Chemistry Products THC Reagent: For in vitro diagnostic use only. VITROS Chemistry Products THC Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of cannabinoids (THC) in human urine using a cutoff of either 20 ng/mL or 50 ng/mL. Measurements obtained with the VITROS THC method are used in the diagnosis and treatment of cannabinoid use or overdose. The VITROS Chemistry Products THC assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. VITROS Chemistry Products Calibrator Kit 30: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 30 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of cannabinoids (THC). VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems. VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V: For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.

Device Story

VITROS THC assay is a homogeneous enzyme immunoassay for detecting cannabinoids in human urine. Performed on VITROS 5,1 FS Chemistry Systems by professional laboratory personnel. Process: urine sample treated with surfactant; mixed with Reagent 1 (antibodies reactive to delta-9-THC, glucose-6-phosphate, NAD+) and Reagent 2 (delta-9-THC labeled with G6P-DH enzyme). Competition occurs between sample THC metabolites and enzyme-labeled THC for antibody binding sites. Enzyme activity is inversely proportional to THC concentration; active enzyme converts NAD+ to NADH, causing absorbance change measured spectrophotometrically at 340 nm. Output is qualitative or semi-quantitative THC concentration. Results are preliminary and require GC/MS confirmation. Clinical decision-making relies on professional judgment alongside test results to assess cannabinoid use or overdose.

Clinical Evidence

Bench testing only. Precision evaluated over 22 days (mean within-lab CV 3.5%). Linearity confirmed (R²=0.999) across 5.0–80 ng/mL range. Analytical specificity and interference testing performed. Method comparison study (n=113) against predicate showed 96.5% overall agreement at 20 ng/mL and 94.7% at 50 ng/mL. Comparison against GC/MS reference method showed 77.0% overall agreement at 20 ng/mL and 88.5% at 50 ng/mL.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: liquid, ready-to-use. Antibody: mouse monoclonal reactive to delta-9-THC. Calibrator/Control matrix: human urine. Detection: spectrophotometric absorbance at 340 nm. Instrumentation: VITROS 5,1 FS Chemistry System (automated).

Indications for Use

Indicated for professional laboratory use in the semi-quantitative or qualitative determination of cannabinoids (THC) in human urine for the diagnosis and treatment of cannabinoid use or overdose. Not for definitive diagnosis; requires GC/MS confirmation.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• SYVA® EMIT® II Plus Cannabinoid Assay (k011300)
• BIO-RAD® LiquichekTM Urine Toxicology Controls (k022707)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics, a Johnson & Johnson company. Above the logo is the date DEC 28 2006. The logo includes a symbol to the left of the company name. The text is in a simple, sans-serif font.

Johnson Johnson company

100 Indigo Creek Drive
Rochester, New York 14626-5101

## 5.0 510(k) Summary

| This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of SMDA 1990 and 21<br>CFR 807.92. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The assigned 510(k) number is: K 063164 | | |
| 1. | Submitter<br>name,<br>address,<br>contact | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive<br>Rochester, New York 14626-5101<br>[phone]<br>Contact Person: Michael M. Byrne |
| 2. | Preparation<br>Date | October 17, 2006 |
| | 3. Device name | Trade or Proprietary Names:<br>VITROS Chemistry Products THC Reagent<br>VITROS Chemistry Products Calibrator Kit 30<br>VITROS Chemistry Products FS Calibrator 1<br>VITROS Chemistry Products DAT Performance Verifiers<br>I, II, III, IV & V |
| | | Common Names:<br>Cannabinoid (THC) assay and controls |
| | | Classification Names:<br>Cannabinoid test system (862.3870) Class II<br>Clinical toxicology calibrators (862.3200) Class II<br>Clinical toxicology control material (862.3280) Class I, VITROS DAT<br>Performance Verifiers are assayed controls, therefore they meet the<br>reserved criteria under Section 510(l) of the Food, Drug and<br>Cosmetic Act. |
| 4. | Predicate<br>Devices | The VITROS THC assay is substantially equivalent to the SYVA®<br>EMIT® II Plus Cannabinoid Assay. |
| | | The VITROS DAT Performance Verifiers are substantially equivalent to<br>the BIO-RAD LiquichekTM Urine Toxicology Controls.<br>Continued on next page |

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5. Device The VITROS THC assay is a homogeneous enzyme immunoassay that is description performed using the VITROS THC Reagent with the VITROS Calibrator Kit 30, VITROS FS Calibrator 1 and VITROS FS Diluent Pack 4 (DAT Diluent / DAT Diluent 2) on VITROS 5,1 FS Chemistry Systems.

> The VITROS THC Reagent is a dual chambered package containing ready-to-use liquid reagents that are used to detect cannabinoids in urine. Sample, calibrators, and controls are automatically treated with surfactant (DAT Diluent 2) prior to addition of reagents. Treated sample is added to Reagent 1 containing antibodies reactive to delta-9-tetrahydrocannabinol (delta-9-THC), glucose-6-phosphate and nicotinamide adenine dinucleotide (NAD+), followed by Reagent 2 containing delta-9-THC labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH), The assay is based on competition between delta 9-THC metabolites in the treated urine sample and the delta 9 -THC labeled with the enzyme glucose-6-phosphate dehydrogenase (G6P-DH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, therefore the concentration of delta-9-THC metabolites in the urine sample is directly proportional to measured enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD+) to NADH, resulting in an absorbance change that is measured spectrophotometrically at 340 nm.

VITROS Calibrator Kit 30 is prepared from human urine to which analyte, surfactant, and preservatives have been added. The VITROS FS Calibrator 1 is composed of processed water and 0.9% w/v sodium chloride (Saline). These calibrators are used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semiquantitative measurement of cannabinoids (THC).

VITROS DAT Performance Verifiers I, II, III, IV and V are prepared from a human urine pool to which analytes, surfactant, and preservative have been added. These are assayed controls used to monitor performance of the VITROS THC assay on VITROS 5,1 FS Chemistry Systems.

The VITROS FS Diluent Pack 4 (DAT Diluent/ DAT Diluent 2) is a common reagent that is used with several drugs of abuse assays to dilute calibrators and samples on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. DAT Diluent is prepared from human urine to which organic salt, surfactants, and preservative have been added. DAT Diluent 2 is prepared from processed water to which surfactant and preservative have been added.

Continued on next page

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## 510(k) Summary (continued)

| 5. Device<br>description<br>(continued) | The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument<br>that provides automated use of the VITROS MicroTip® and MicroSlides®<br>range of products. The VITROS 5,1 FS System was cleared for market by<br>510(k) Premarket Notification (K031924). |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. Device<br>intended uses | VITROS Chemistry Products THC Reagent: For <i>in vitro</i> diagnostic<br>use only. VITROS Chemistry Products THC Reagent is used on VITROS<br>5,1 FS Chemistry Systems for the semi-quantitative or qualitative<br>determination of cannabinoids (THC) in human urine using a cutoff of<br>either 20 ng/mL or 50 ng/mL. Measurements obtained with the VITROS<br>THC method are used in the diagnosis and treatment of cannabinoid use<br>or overdose.<br><br>The VITROS Chemistry Products THC assay is intended for use by<br>professional laboratory personnel. It provides only a preliminary test<br>result. A more specific alternative chemical method must be used to<br>confirm a result obtained with this assay. Gas chromatography/mass<br>spectrometry (GC/MS) is the preferred confirmatory method. Clinical<br>consideration and professional judgment should be applied to any drug-<br>of-abuse test result, particularly when evaluating a preliminary positive<br>result.<br><br>VITROS Chemistry Products Calibrator Kit 30: For <i>in vitro</i><br>diagnostic use only. VITROS Chemistry Products Calibrator Kit 30 is<br>used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or<br>semi-quantitative measurement of cannabinoids (THC).<br><br>VITROS Chemistry Products FS Calibrator 1: For <i>in vitro</i> diagnostic<br>use only. VITROS Chemistry Products FS Calibrator 1 is used in<br>conjunction with VITROS Chemistry Products Calibrator Kits to calibrate<br>VITROS 5,1 FS Chemistry Systems.<br><br>VITROS Chemistry Products DAT Performance Verifiers I, II, III,<br>IV and V: For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products<br>DAT Performance Verifiers are assayed controls used to monitor<br>performance of urine drugs of abuse screening assays on VITROS 5,1 FS<br>Chemistry Systems. |

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- 7. The VITROS THC assay and VITROS DAT Performance Verifiers are Comparison substantially equivalent to the SYVA® EMIT® II Plus Cannabinoid Assay to predicate (K011300 and K993984) and BIO-RAD® Liquichek™ Urine Toxicology devices Controls (K022707) (predicate devices) which were cleared by the FDA for in vitro diagnostic use.
The performance of the VITROS THC assay on the VITROS 5,1 FS Chemistry System was compared to the SYVA® EMIT® II Plus Cannabinoid assay on the OLYMPUS® AU400™ System for the 50 ng/ml cutoff and the SYVA® 30R Biochemical System for the 20 ng/mL cutoff. The results demonstrated good agreement between each of the immunoassay methods.

The VITROS THC assay and the VITROS DAT Performance Verifiers have the following similarities to the predicate device: the same intended use, consist of liquid, ready to use reagents, have similar performance characteristics, are used on an automated clinical chemistry analyzer and calibrated against the same drug metabolite, 11-nor-delta-9-THC-9-COOH.

In addition to correlation studies, bench testing was performed to determine assay precision, linearity, specificity, limit of detection, and stability of the VITROS THC assay.

- Table 1 Similarities and differences of the assays and control fluids performed using the new and predicate devices.

| Device Similarities | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device Characteristic | Description |
| Indications for Use | The assays are intended for use in the qualitative and semi-quantitative analysis of cannabinoids in human urine. |
| Test Principle | Homogeneous enzyme immunoassay |
| Sample Type | Human Urine |
| Reagent Format | Liquid ready to use |
| Antibody source | Mouse monoclonal antibodies reactive to delta 9-tetrahydrocannabinol |
| Calibrator analyte | 11-nor-delta-9-THC-9-COOH |
| Calibrator and Control format | Refrigerated: Liquid, ready to use |
| Calibrator matrix | Human urine |
| Control matrix | Human urine |

Continued on next page

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| | | Table 1 (con't from previous page) | |
|--|--|------------------------------------|--|
| | | MAR AND CONSULE | |

| Device Differences | | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | VITROS THC assay<br>(New device) | SYVA EMIT II Plus Cannabinoid<br>assay and Liquichek™ Controls<br>(Predicate devices) |
| Number of Calibrator<br>levels | Six | Three for Qualitative<br>Four for Semi-Quantitative |
| Instrumentation | VITROS 5,1 FS Chemistry<br>Systems | Multiple clinical chemistry systems |
| Cutoff Values | 20 and 50 ng/mL | 20, 50, and 100 ng/mL |
| Cutoff Types | Qualitative and Semi-<br>Quantitative for 20 and 50<br>ng/mL | Qualitative for 20, 50, and 100<br>ng/mL<br>Semi-Quantitative for 50 and 100<br>ng/mL (OLYMPUS)<br>Semi-Quantitative for the 20, 50,<br>and 100 ng/mL (Syva 30R) |
| Control claimed<br>analytes | Cocaine metabolites<br>(benzoylecgonine),<br>benzodiazepines<br>(lormetazepam), methadone,<br>amphetamines (d-<br>methamphetamine), opiates<br>(morphine), cannabinoids (11-<br>nor-delta-9-THC-9-COOH),<br>phencyclidine and barbiturates<br>(secobarbital). | Methamphetamine, secobarbital,<br>lormetazepam,<br>tetrahydrocannabinol (THC),<br>benzoylecgonine, ethanol, lysergic<br>acid diethylamide (LSD),<br>methadone, methaqualone,<br>morphine, (Free), phencyclidine,<br>propoxyphene, nortriptyline and<br>addition of creatinine, pH, specific<br>gravity. |
| Control: Number of<br>levels | Five | Two |

8. Conclusions The data presented in the premarket notification provide a reasonable assurance that the VITROS THC Reagent, VITROS Calibrator Kit 30, VITROS FS Calibrator 1 and VITROS DAT Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with its wings spread, rendered in a simple, bold line drawing. The eagle's head is not visible, and its body is represented by flowing lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Michael M. Byrne, RAC Regulatory Affairs MC00881 Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

DEC 2 8 2006

Re: k063164

Trade Name: VITROS Chemistry Products THC Reagent, Calibrator Kit 30, FS calibrator 1, and DAT Performance Verifiers I, II, III, IV, and V Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid (THC) Test System Product Code: LDJ, DLJ, DKB, Class II - DIF, Class I (reserved) Dated: October 17, 2006 Received: October 18, 2006

Dear Mr. Byrne:

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, permite 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 onte the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 80.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its coll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. 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

Page 1 of 2

510(k) Number (if known):

1663164

Device Name: VITROS Chemistry Products THC Reagent

For in vitro diagnostic use only. VITROS Chemistry Products THC Indications Reagent is used on VITROS 5,1 FS Chemistry Systems for the semifor Use: quantitative or qualitative determination of cannabinoids (THC) in human urine using a cutoff of either 20 ng/mL or 50 ng/mL. Measurements obtained with the VITROS THC method are used in the diagnosis and treatment of cannabinoid use or overdose.

> The VITROS Chemistry Products THC assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugof-abuse test result, particularly when evaluating a preliminary positive result.

Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 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)

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(k) *K163164*

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## Indications for Use

Page 2 of 2

| 510(k) Number (if known): | k063164 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: VITROS Chemistry Products Calibrator Kit 30 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V

Indications For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit for Use: 30 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of cannabinoids (THC).

> For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.

For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.

| Prescription Use | AND/OR | Over-The-Counter Use |
|------------------------------------|--------|------------------------------------|
| _X_<br>(Part 21 CFR 801 Subpart D) | | ________<br>(21 CFR 807 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)