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 Description

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AI/ML Overview

The Syva Emit® II Plus Cannabinoid Assay is a homogeneous enzyme immunoassay intended for qualitative and semiquantitative analyses of cannabinoids in human urine, with three different cutoff protocols: 20 ng/mL, 50 ng/mL, and 100 ng/mL. The studies provided demonstrate the device's performance against established predicate methods.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents performance data for three protocols (20 ng/mL, 50 ng/mL, and 100 ng/mL). The acceptance criteria are implicitly defined by the reported performance relative to the predicate devices and the internal precision and sensitivity targets.

Protocol: 20 ng/mL

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Comparative Analysis	High correlation and agreement with predicate method	100% agreement with Emit® II Cannabinoid 20 ng Assay (predicate method) in finding samples negative and positive.
Spiked Sample Recovery	Correct identification of spiked specimens around cutoff.	Correctly identified spiked specimens: <= -25% of cutoff as negative, >= +25% of cutoff as positive.
Semiquantitative Recovery	Recovery within an acceptable range of nominal concentrations for spiked analytes.	79%-106% recovery of nominal concentrations for THC levels 15-55 ng/mL.
Precision (Qualitative)	Acceptable within-run and total precision (%CV).	Within-run %CV: 0.5-0.8%; Total %CV: 1.4-2.6%.
Precision (Semiquantitative)	Acceptable within-run and total precision (%CV).	Within-run %CV: 1.8-2.3%; Total %CV: 4.9-6.7%.
Sensitivity	Lowest concentration distinguishable from 0 ng/mL with 95% confidence.	< 10 ng/mL (for 11-nor-Δ3-THC-9-carboxylic acid)

Protocol: 50 ng/mL

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Comparative Analysis	High correlation and agreement with predicate method	100% agreement with Emit® II Cannabinoid 50 ng Assay (predicate method) in finding samples negative and positive.
Spiked Sample Recovery	Correct identification of spiked specimens around cutoff.	Correctly identified spiked specimens: <= -25% of cutoff as negative, >= +25% of cutoff as positive.
Semiquantitative Recovery	Recovery within an acceptable range of nominal concentrations for spiked analytes.	86%-118% recovery of nominal concentrations for Cannabinoids levels 25-180 ng/mL.
Precision (Qualitative)	Acceptable within-run and total precision (%CV).	Within-run %CV: 0.6-0.7%; Total %CV: 1.4-2.1%.
Precision (Semiquantitative)	Acceptable within-run and total precision (%CV).	Within-run %CV: 1.3-1.5%; Total %CV: 2.8-5.4%.
Sensitivity	Lowest concentration distinguishable from 0 ng/mL with 95% confidence.	< 15 ng/mL (for 11-nor-g-THC-9-carboxylic acid)

Protocol: 100 ng/mL

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Comparative Analysis	High correlation and agreement with predicate method	99% agreement with Emit® II Cannabinoid 100 ng Assay (predicate method) in finding samples negative and positive.
Spiked Sample Recovery	Correct identification of spiked specimens around cutoff.	Correctly identified spiked specimens: <= -25% of cutoff as negative, >= +25% of cutoff as positive.
Semiquantitative Recovery	Recovery within an acceptable range of nominal concentrations for spiked analytes.	80%-106% recovery of nominal concentrations for Cannabinoids levels 15-180 ng/mL.
Precision (Qualitative)	Acceptable within-run and total precision (%CV).	Within-run %CV: 0.6-0.7%; Total %CV: 1.4-2.0%.
Precision (Semiquantitative)	Acceptable within-run and total precision (%CV).	Within-run %CV: 2.1-2.7%; Total %CV: 6.0-7.4%.
Sensitivity	Lowest concentration distinguishable from 0 ng/mL with 95% confidence.	< 10 ng/mL (for 11-nor-Δ³-THC-9-carboxylic acid)

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

The document does not explicitly state the exact sample sizes for each test (e.g., comparative analysis, spiked sample recovery, precision studies). However, for the semiquantitative recovery, it mentions that "Negative human urine specimens were spiked with concentrations of cannabinoids (THC) at levels throughout the specified range." The exact number of specimens is not provided.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be laboratory-based testing conducted by the manufacturer (Syva Company - Dade Behring Inc.).

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

This is an immunoassay device, and "experts" in the context of diagnostic imaging or clinical interpretation are not relevant here. The ground truth for comparative analysis, spiked sample recovery, and sensitivity is established by:

Predicate methods: The Emit® II Cannabinoid Assays (20 ng, 50 ng, 100 ng) are used as the reference for comparative analysis.
Known spiked concentrations: For spiked sample recovery and semiquantitative recovery, the ground truth is the precisely known concentration of cannabinoids added to the urine samples.
Statistical analysis: Sensitivity is determined statistically based on the ability to distinguish a signal from 0 ng/mL.

Therefore, there were no human "experts" in a diagnostic interpretation sense used to establish ground truth for this type of in vitro diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As an immunoassay, the device provides quantitative or qualitative results based on chemical reactions and optical detection. There is no human interpretation of results requiring adjudication. The comparison criteria are based on agreement with a predicate method or known spiked concentrations.

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

Not applicable. This is an in vitro diagnostic device (immunoassay) and not an AI-powered diagnostic imaging tool or a system that involves human readers interpreting cases. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant.

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

The studies presented are inherently "standalone" in the sense that they evaluate the performance of the assay itself (chemical reactions and detection) without human interpretive intervention. The device's output (qualitative positive/negative or semiquantitative concentration) is directly compared to the ground truth.

7. The Type of Ground Truth Used:

The ground truth used in these studies consists of:

Predicate Device Results: For comparative analysis, the results from the legally marketed Emit® II Cannabinoid Assays (20 ng, 50 ng, 100 ng) serve as the reference.
Known Spiked Concentrations: For spiked sample recovery and semiquantitative recovery, the ground truth is the precisely known concentration of 11-nor-ΔTHC-9-carboxylic acid (or cannabinoids more generally) that was added to the negative human urine specimens.
Statistical Thresholds: For sensitivity, the ground truth is a statistically defined limit of detection based on the response at 0 ng/mL.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its size. For an immunoassay, the "training" analogous to machine learning typically involves optimization of reagents, reaction conditions, and calibration curve development by the manufacturer during the assay development phase. The provided data focuses on the validation of the finalized assay.

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

Not applicable, as a distinct training set with established ground truth, similar to those used in AI or machine learning studies, is not described for this immunoassay device. The development process would involve internal controls, reference materials, and established analytical chemistry principles to optimize assay performance.

Summary

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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.

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.

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 (770) 488-7655.

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 (301) 594-4639. 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 (800) 638 2041 or (301) 443-6597, 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:

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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Device Name: Emit® II Plus Cannabinoid Assay

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
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 includedelta -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.(b)
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).