(69 days)
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No
The description details a standard enzyme immunoassay for drug detection, which relies on chemical reactions and spectrophotometric analysis, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic (IVD) test intended for qualitative and semi-quantitative analysis of cannabinoids in human urine to detect the presence of substances, not to treat a condition or disease.
Yes
The "Intended Use / Indications for Use" states that the assay is "intended for use in the qualitative and semi-quantitative analyses of cannabinoids (THC) in human urine" and provides a "preliminary analytical test result." This indicates its use in identifying the presence of a specific substance in a biological sample, which directly aligns with the purpose of a diagnostic device.
No
The device is a liquid reagent, homogeneous enzyme immunoassay, which is a chemical assay and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative analyses of cannabinoids (THC) in human urine." This is a test performed on a biological sample (urine) outside of the body to gain information about a person's health status (in this case, the presence of THC).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses specific antibodies to detect THC in human urine. This is a common method used in IVD devices for analyzing biological samples.
- Anatomical Site: The sample is "human urine," which is a biological specimen.
- Intended User / Care Setting: It's designed for "professional use with a number of automated clinical chemistry analyzers," indicating it's used in a clinical or laboratory setting by trained professionals.
- Performance Studies: The document describes performance studies evaluating characteristics like precision, sensitivity, accuracy, analytical recovery, and specificity, which are standard evaluations for IVD devices.
- Predicate Device: A predicate device (K943998; Cannabinoid (THC) Enzyme Immunoassay) is listed, which is another IVD device. This further supports the classification of this device as an IVD.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cannabinoid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SHAHSA recommended initial test cutoff concentration), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of cannabinoids (THC) in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Cannabinoid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Product codes
LDJ
Device Description
LZI's Cannabinoid Enzyme Immunoassay is a ready-to-use liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect cannabinoids (THC) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between Δ - THC-labeled glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use with a number of automated clinical chemistry analyzers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
The Cannabinoid Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.
Precision: (Illustrated with THC 50 assay results)
- Within Run Precision (Qualitative):
- Negative: Mean Rate 318.7, SD 2.2, %CV 0.68
- 20 ng/mL: Mean Rate 346.3, SD 2.5, %CV 0.72
- 50 ng/mL: Mean Rate 398.7, SD 3.5, %CV 0.87
- 100 ng/mL: Mean Rate 456.0, SD 3.3, %CV 0.73
- 200 ng/mL: Mean Rate 475.1, SD 1.9, %CV 0.39
- Within Run Precision (Semi-quantitative):
- 37.5 ng/mL: Mean Conc 38.3, SD 0.8, %CV 2.12
- 50 ng/mL: Mean Conc 50.0, SD 1.4, %CV 2.78
- 62.5 ng/mL: Mean Conc 65.1, SD 1.9, %CV 2.91
- Run-To-Run Precision (Qualitative):
- Negative: Mean Rate 320.5, SD 3.1, %CV 0.96
- 20 ng/mL: Mean Rate 347.6, SD 2.3, %CV 0.66
- 50 ng/mL: Mean Rate 399.8, SD 3.9, %CV 0.97
- 100 ng/mL: Mean Rate 457.6, SD 4.0, %CV 0.88
- 200 ng/mL: Mean Rate 477.1, SD 3.5, %CV 0.73
- Run-To-Run Precision (Semi-quantitative):
- 37.5 ng/mL: Mean Conc 37.1, SD 0.9, %CV 2.41
- 50 ng/mL: Mean Conc 48.4, SD 1.5, %CV 3.02
- 62.5 ng/mL: Mean Conc 63.9, SD 2.3, %CV 3.59
Sensitivity:
- 5 ng/mL (THC 20 assay)
- 7.5 ng/mL (THC 50 assay)
- 15 ng/mL (THC 100 assay)
Accuracy:
- Vs. DRI's Cannabinoid EIA (n = 216)
- THC 20 assay: Positive Samples 100% Agreement, Negative Samples 100% Agreement
- THC 50 assay: Positive Samples 100% Agreement, Negative Samples 100% Agreement
- THC 100 assay: Positive Samples 98.3 % (1 marginal discrepant), Negative Samples 100% Agreement
Analytical Recovery: (Illustrated with THC 50 assay)
- Qualitative: 100 % accuracy on positive vs. negative tests
- Semi-quantitative: Quantitate within ±12% of the nominal concentration between 10 ng/mL and 95 ng/mL. Average 98.7 % recovery at 37.5 ng/mL level (Cutoff - 25%). Average 93.2 % recovery at 62.5 ng/mL level (Cutoff + 25%).
Specificity: Comparable to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity:
- 5 ng/mL (THC 20 assay)
- 7.5 ng/mL (THC 50 assay)
- 15 ng/mL (THC 100 assay)
- Accuracy (Agreement):
- THC 20 assay: Positive Samples 100% Agreement, Negative Samples 100% Agreement
- THC 50 assay: Positive Samples 100% Agreement, Negative Samples 100% Agreement
- THC 100 assay: Positive Samples 98.3 % (1 marginal discrepant), Negative Samples 100% Agreement
- Analytical Recovery:
- Qualitative: 100 % accuracy on positive vs. negative tests
- Semi-quantitative: Quantitate within ±12% of the nominal concentration between 10 ng/mL and 95 ng/mL. Average 98.7 % recovery at 37.5 ng/mL level (Cutoff - 25%). Average 93.2 % recovery at 62.5 ng/mL level (Cutoff + 25%).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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AUG 1 5 2002
KC21887
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safetv and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name. Address, and Contact
Lin-Zhi International, Inc. 2391 Zanker Road, Suite 340 San Jose, CA 95131-1124 Phone: (408) 944-0360 Fax: (408) 944-0359
Chiu Chin Chang, Ph.D. Contact: VP, R&D
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Cannabinoids,
Class II, LDJ (91 Toxicology), 21CFR 862.3870 |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous enzyme immunoassay for the determination
of cannabinoids (THC) level in urine. |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.'s Cannabinoid Enzyme Immunoassay is substantially equivalent to the Cannabinoid (THC) Enzyme Immunoassay (By DRJMicrogenics Corp.), cleared under premarket notification K943998.
LZI's Cannabinoid Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
LZI's Cannabinoid Enzyme Immunoassay is a ready-to-use liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect cannabinoids (THC) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between Δ - THC-labeled glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed
1
amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Cannabinoid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA recommended initial test cutoff concentration), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of cannabinoids (THC) in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
Comparison to Predicate Device
LZI's Cannabinoid Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed Cannabinoid (THC) Enzyme Immunoassay (K943998) by Diagnostic Reagents, Inc. (DRI, now Microgenics Corporation)
The following table compares LZI's Cannabinoid Enzyme Immunoassay with the predicate device, DRI's Cannabinoid (THC) Enzyme Immunoassay.
Similarities:
- . Both assays are for qualitative and semi-quantitative determination of cannabinoids in human urine.
- Both assays use the same method principle, and device components. .
- Both assays can be used with a 20 ng/mL, 50 ng/mL (Cutoff level per . recommendations of The Substance Abuse and Metal Health Services Administration, or SAMHSA), or 100 ng/mL cutoff.
- The same 5 calibrators were used for qualitative analyses of the assay. .
Differences:
- In the semi-quantitative analysis of cannabinoids concentration in urine. LZI's . Cannabinoid Enzyme Immunoassay uses a specified 5 calibrators set for each cutoff assay. DRI's Cannabinoid (THC) EIA used the same 5 calibrators for both qualitative analyses and the semi-quantitative analyses purposes.
2
(Comparison to Predicate Device, continued)
| Feature | DRI's Cannabinoid (THC) EIA | LZI's Cannabinoid EIA | |||||
|---|---|---|---|---|---|---|---|
| Within Run Precision: | (Illustrated with THC 50 assay results) | ||||||
| Qualitative: | Mean Rate | SD | % CV | Mean Rate | SD | % CV | |
| Negative | 287 | 1.0 | Negative | 318.7 | 2.2 | 0.68 | |
| 20 ng/mL | 317 | 0.9 | 20 ng/mL | 346.3 | 2.5 | 0.72 | |
| 50 ng/mL | 387 | 0.9 | 50 ng/mL | 398.7 | 3.5 | 0.87 | |
| 100 ng/mL | 447 | 0.9 | 100 ng/mL | 456.0 | 3.3 | 0.73 | |
| 200 ng/mL | 472 | 0.5 | 200 ng/mL | 475.1 | 1.9 | 0.39 | |
| Semi-quantitative: | No data available. | Mean Conc | SD | % CV | |||
| 37.5 ng/mL | 38.3 | 0.8 | 2.12 | ||||
| 50 ng/mL | 50.0 | 1.4 | 2.78 | ||||
| 62.5 ng/mL | 65.1 | 1.9 | 2.91 | ||||
| Run-To-Run Precision: | (Illustrated with THC 50 assay results) | ||||||
| Qualitative: | Mean Rate | SD | % CV | Mean Rate | SD | % CV | |
| Negative | 287 | 1.0 | Negative | 320.5 | 3.1 | 0.96 | |
| 20 ng/mL | 319 | 0.7 | 20 ng/mL | 347.6 | 2.3 | 0.66 | |
| 50 ng/mL | 388 | 1.0 | 50 ng/mL | 399.8 | 3.9 | 0.97 | |
| 100 ng/mL | 449 | 1.2 | 100 ng/mL | 457.6 | 4.0 | 0.88 | |
| 200 ng/mL | 473 | 0.8 | 200 ng/mL | 477.1 | 3.5 | 0.73 | |
| Semi-quantitative: | No data available. | Mean Conc | SD | % CV | |||
| 37.5 ng/mL | 37.1 | 0.9 | 2.41 | ||||
| 50 ng/mL | 48.4 | 1.5 | 3.02 | ||||
| 62.5 ng/mL | 63.9 | 2.3 | 3.59 | ||||
| Sensitivity: | 10 ng/mL | 5 ng/mL | (THC 20 assay); | ||||
| 7.5 ng/mL | (THC 50 assay); | ||||||
| 15 ng/mL | (THC 100 assay) | ||||||
| Accuracy: | Vs. GC/MS* (n = 592) | Vs. DRI s Cannabinoid EIA (n = 216) | |||||
| THC 20 assay | THC 50 assay | THC 100 assay | THC 20 assay | THC 50 assay | THC 100 assay | ||
| Positive Samples: | No data | 100% Agreement | 6 borderline negative found | 100 % Agreement | 100 % Agreement | 98.3 % (1 marginal discrepant) | |
| Negative Samples: | No data | 100% Agreement | 100% Agreement | 100 % Agreement | 100 % Agreement | 100 % Agreement | |
| Analytical Recovery: | (Illustrated with THC 50 assay) | ||||||
| Qualitative: No data available | 100 % accuracy on positive vs. negative tests | ||||||
| Semi-quantitative: No data available | Quantitate within ±12% of the nominal concentration between 10 ng/mL and 95 ng/mL. | ||||||
| Average 98.7 % recovery at 37.5 ng/mL level (Cutoff - 25%) | |||||||
| Average 93.2 % recovery at 62.5 ng/mL level (Cutoff + 25%) | |||||||
| Specificity: | See attached DRI s Cannabinoid (THC) EIA package insert | Comparable to the predicate device. |
Performance Characteristics
- A 15 ng/mL cutoff for GC/MS was used for comparison.
3
Conclusion
LZI's Cannabinoid Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.
We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Cannabinoid Enzyme Immunoassay to other cannabinoid test systems currently marketed in the United States.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 5 2002
Chiu Chin Chang, Ph.D. VP. R & D Lin-Zhi International, Inc. . 2391 Zanker Road. Suite 340 San Jose, CA 95131-1124
Re: K021887
Trade/Device Name: Cannabinoid Enzyme Immunoassay Regulation Number: 21 CFR 862. 3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: June 5, 2002 Received: June 7, 2002
Dear Dr. Chang:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
Premarket Notification -
Indications for Use Statement
510(k) Number (if known): K021887
Device Name: Cannabinoid Enzyme Immunoassay
Indications for Use:
The Cannabinoid Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SHAHSA recommended initial test cutoff concentration), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of cannabinoids (THC) in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Cannabinoid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
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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)