(55 days)
Emit® II Cannabinoid 20 ng Assay, Emit® II Cannabinoid 50 ng Assay, Emit® II Cannabinoid 100 ng Assay
Emit® II Cannabinoid 20 ng Assay, Emit® II Cannabinoid 50 ng Assay, Emit® II Cannabinoid 100 ng Assay
No
The summary describes a standard enzyme immunoassay for drug testing and does not mention any AI or ML components. The performance studies focus on traditional analytical metrics like correlation, recovery, precision, and sensitivity.
No
The device is an in vitro diagnostic assay used for the qualitative and semiquantitative analysis of cannabinoids in human urine. It is not intended for therapeutic purposes.
Yes
The device is intended for the qualitative and semiquantitative analyses of cannabinoids in human urine, which is a diagnostic purpose.
No
The device is described as an "enzyme immunoassay" and is intended for use with "chemistry analyzers," indicating it is a chemical assay kit and requires hardware (chemistry analyzers) for its function, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative and semiquantitative analyses of cannabinoids in human urine." This indicates that the device is used to examine a specimen (human urine) in vitro (outside the body) to provide information about a person's health or condition (the presence and amount of cannabinoids).
- Anatomical Site: The anatomical site is "human urine," which is a biological specimen collected from the body for analysis.
- Performance Studies: The document details performance studies like Comparative Analysis, Spiked Sample Recovery, Precision, and Sensitivity, which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device(s): The mention of predicate devices (Emit® II Cannabinoid 20 ng Assay, Emit® II Cannabinoid 50 ng Assay, Emit® II Cannabinoid 100 ng Assay) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
The core function of the device is to analyze a biological sample (urine) outside the body to detect and quantify a substance (cannabinoids), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LDJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Analysis: The Syva Emit® II Plus Cannabinoid Assay showed excellent correlation to the Emit® II Cannabinoid 20 ng Assay (predicate method). The comparative correlation to the Emit® II Cannabinoid Assay 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 specimens containing the 20 ng/mL Cutoff as negative and the spiked equal to of less 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%.
Sensitivity: 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%.
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 () 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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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%.
Sensitivity: 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%.
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%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Emit® II Cannabinoid 20 ng Assay, Emit® II Cannabinoid 50 ng Assay, Emit® II Cannabinoid 100 ng Assay
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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 () 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 () 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 (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
6
510(k) Number (if known):
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