SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL

K993984 · Syva Co. · LDJ · Jan 18, 2000 · Clinical Toxicology

Device Facts

• Record ID: K993984
• Device Name: SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
• Applicant: Syva Co.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Emit® II Plus Cannabinoid Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cannabinoids in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

Device Story

Emit® II Plus Cannabinoid Assay is a homogeneous enzyme immunoassay for detecting cannabinoids in human urine. Device processes urine samples on automated chemistry analyzers; utilizes enzyme-linked reaction to measure drug concentration. Provides qualitative (positive/negative relative to 20, 50, or 100 ng/mL cutoffs) and semiquantitative results. Used in clinical laboratory settings by trained personnel. Output assists healthcare providers in identifying cannabinoid presence; supports clinical decision-making regarding substance use. Benefits include standardized, automated screening for drug abuse monitoring.

Clinical Evidence

Bench testing only. Comparative analysis against predicate assays showed 99-100% agreement. Spiked sample recovery demonstrated accuracy within 79-118% of nominal concentrations across semiquantitative ranges. Precision studies (within-run and total) reported %CVs ranging from 0.5% to 7.4% depending on mode and cutoff. Sensitivity (limit of detection) reported as <10 ng/mL for 20/100 ng/mL protocols and <15 ng/mL for 50 ng/mL protocol, with 95% confidence.

Technological Characteristics

Homogeneous enzyme immunoassay; liquid reagent format. Designed for use on automated chemistry analyzers. Measures 11-nor-Δ9-THC-9-carboxylic acid. Qualitative and semiquantitative modes. No specific materials of construction or connectivity standards provided.

Indications for Use

Indicated for qualitative and semiquantitative analysis of cannabinoids in human urine for drugs-of-abuse testing. Intended for use with chemistry analyzers.

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

• Emit® II Cannabinoid 20 ng Assay
• Emit® II Cannabinoid 50 ng Assay
• Emit® II Cannabinoid 100 ng Assay

Submission Summary (Full Text)

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JAN 18 2000

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Syva Emit® II Plus Cannabinoid Assay

#### 20 ng/mL Protocol

Comparative Analysis: The Syva Emit® II Plus Cannabinoid Assay showed excellent Comparative Analysis. The Oyva Link
correlation to the Emit® II Cannabinoid 20 ng Assay (predicate method). The comparative correlation to the Emil - if Ourmatine of in 100% agreement in finding samples negative and positive.

Spiked Sample Recovery: Analysis of spiked sample recovery by the qualitative mode of Spiked Gample Roovery. And Assay correctly identified the spiked specimens containing the Child This Oanhabinold About Corony Coronial Cutoff as negative and the spiked equal to of less than ( > ) mind ( ) reater than (>) plus (+) 25% of 20 ng/mL cutoff as positive.

The semiquantitative attribute was assessed by determining the accuracy of recovery for The Semiqualitiative attinotic was desected by assay. Negative human urine anaryo opikou sampled with concentrations of cannabinoids (THC) at levels throughout the specificative range of 15 to 55 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit® II Plus Cannabinoid Assay. Within this range, recovery was within 79%-106% of nominal concentrations of spiked analyte.

Precision: A precision study was performed using Syva Emit® II Plus Cannabinoid Assay in both the qualitative and semiquantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative modes of the assays were observed.

In the qualitative mode of the Emit®11 Cannabinoid Assay, the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.5 - 0.8% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 1.4 - 2.6%.

In the semiquantitative mode of the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (concentrations) ranging from 1.8 – 2.3% and total precision with coefficients of variation (%CV) for controls and cutoff (concentration) ranging from 4.9 - 6.7%.

Sensitivity: The sensitivity level of the Emit® II Plus Cannabinoid Assay is less than 10 ng/mL. This level represents the lowest concentration of 11-nor-Δ3-THC-9-carboxylic acid that can be distinguished from 0 ng/mL with a confidence level of 95%.

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## For Syva Emit® II Plus Cannabinoid Assay (cont.)

#### 50 ng/mL Protocol

Comparative Analysis: The Syva Emit® II Plus Cannabinoid Assay showed excellent correlation to the Emit® II Cannabinoid 50 ng Assay (predicate method). The comparative analysis to the predicate method resulted in 100% agreement in finding samples negative and positive.

Spiked Sample Recovery: Analysis of spiked sample recovery by the qualitative mode of the Emit® II Plus Cannabinoid Assay correctly identified the spiked speciments containing equal to or less than (<) minus (-) 25% of the 50 ng/mL cutoff as negative and the spiked specimens containing equal to or greater than (>) plus (+) 25% of 50 ng/mL nut nff ss positive.

The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus cannabinoid (THC) Assay. Negative human urine specimens were spiked with concentrations of Cannabinoids at levels throughout the semiquantitative range of 25 to 180 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit® II Plus Cannabinoid Assay. Within this range, recovery was within 86%-118% of nominal concentrations of spiked analyte.

Precision: A precision study was performed using Syva Emit® II Plus Cannabinoid Assay in both the qualitative and semiquantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitiative modes of the assays were observed.

In the qualitative mode of the Emit® II Cannabinoid Assay, the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.6 - 0.7% and total precision with coefficients of variation (YCV) for controls and cutoff (rates) ranging from 1.4 – 2.1%.

In the semiquantitative mode of the assay the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (concentrations) ranging from 1,3 – 1.5% and total precision with coefficients of variations) fanging hoff (concentration) ranging from 2.8 – 5.4%.

ട്ടensitivity: The sensitivity level of the Emit® II Plus Cannabinoid Assay is less than 15 ng/mL. This level represents the lowest concentration of 11-nor-g-THC-9-carboxylic acid that can be distinguished from 0 ng/mL with a confidence level of 95%.

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## For Syva Emit® II Plus Cannabinoid Assay (cont.)

## 100 ng/mL Protocol

Comparative Analysis: The Syva Emit® II Plus Cannabinoid Assay showed excellent correlation to the Emit® II Cannabinoid 100 ng Assay (predicate method). The comparative analysis to the predicate method resulted in 99% agreement in finding samples negative and positive.

Spiked Sample Recovery: Analysis of spiked sample recovery by the qualitative mode of the Emit® II Plus Cannabinoid Assay correctly identified the spiked specimens containing equal to or less than (<) minus (-) 25% of the 100 ng/mL cutoff as negative and the spiked specimens containing equal to or greater than (>) plus (+) 25% of 100 ng/mL cutoff as positive.

The semiquantitative attribute was assessed by determining the accuracy of recovery for analyte-spiked samples by the Emit® II Plus Cannabinoid Assay. Negative human urine specimens were spiked with concentrations of Cannabinoids at levels throughout the semiquantitative range of 15 to 180 ng/mL. For each known concentration, drug recovery was calculated using the average concentration obtained by the Emit® II Plus Cannabinoid Assay. Within this range, recovery was within 80%-106% of nominal concentrations of spiked analyte.

Precision: A precision study was performed using Syva Emit® II Plus Cannabinoid Assay in both the qualitative and semiquantitative modes. Acceptable within-run and total precision statistics for both the qualitative and semiquantitative modes of the assays were observed.

In the qualitative mode of the Emit® II Cannabinoid Assay, the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 0.6 - 0.7% and total precision with coefficients of variation (%CV) for controls and cutoff (rates) ranging from 1.4 – 2.0%.

In the semiquantitative mode of the assay the results demonstrated within-run precision with coefficients of variation (%CV) for controls and cutoff (concentrations) ranging from 2.1 – 2.7% and total precision with coefficients of variation (%CV) for controls and cutoff (concentration) ranging from 6.0 - 7.4%.

Sensitivity: The sensitivity level of the Emit® II Plus Cannabinoid Assay is less than 10 ng/mL. This level represents the lowest concentration of 11-nor-Δ³-THC-9-carboxylic acid that can be distinguished from 0 ng/mL with a confidence level of 95%.

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## 5. Substantial Equivalence:

In conclusion, Syva Company - Dade Behring Inc. considers the Syva Emit® II Plus Cannabinoid Assay to be substantially equivalent to the Emit® II Cannabinoid 20 ng Assay, the Emit® II Cannabinoid 50 ng Assay, and the Emit® II Cannabinoid 100 ng Assay with regard to intended use, assay sample, and overall performance characteristics.

:

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Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

JAN 18 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul L. Rogers Jr. Senior Manager, Regulatory Affairs Syva Company - Dade Behring, Inc. P.O. Box 49013 3403 Yerba Buena Road San Jose, California 95161-9013

Re: K993984

> Trade Name: Syva Emit® II Plus Cannabinoid Assay Regulatory Class: II Product Code: LDJ Dated: November 23, 1999 Received: November 24, 1999

Dear Mr. Rogers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commorce 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLA-88), this device may Onder the Chinear Laboratory improvition. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I DA Inding or bassistication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific ad rios for your as ic devices), please contact the Office of Compliance at additionally 807.10 for in villy diagnostions on the promotion and advertising of your device, (301) 594-436. "Additionally, for questions at [phone]. Also, please note the regulation prease contact the Office of Comphanoo at (301) on the montheation"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsionness and its toll-five number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K993984

Device Name: Emit® II Plus Cannabinoid Assay

## Indications for Use:

The Emit® II Plus Cannabinoid Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cannabinoids in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

Sean Coogen

(Division Signa
Division

510(k) N... K 993984

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Device Name: Emit® II Plus Cannabinoid Assay