(148 days)
The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are intended for the qualitative and semi-quantitative determination of Cannabinoids in human urine using 11-nor-A -THC-9-COOH (the major metabolite of THC referred to here as cTHC) as calibrator at the cutoff values of 25, 50, or 100 ng/mL. The assays are designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Cannabinoids (cTHC) Enzyme Immunoassay.
The LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Cannabinoids (cTHC) Enzyme Immunoassay,
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography|mass spectrometry (GC|MS or LC|MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The LZI Cannabinoids (cTHC) 25, 50, and 100 assays are a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assays are based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cannabinoid derivative -labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound cannabinoid derivative - labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are kits comprised of two reagents, an R1 and R2 which are bottled separately but sold together within each kit.
The R1 solution contains a mouse monoclonal anti-cannabinoid antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with a cannabinoid derivative in buffer with sodium azide (0.09%) as preservative.
The LZI Cannabinoids (cTHC) 25 Enzyme Immunoassay calibrators and controls contain 0, 12.5, 18.75, 25, 31.25, 37.5, and 50 ng/mL of 11-nor-a3-THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These seven calibrators and controls are sold as individual bottles.
The LZI Cannabinoids (cTHC) 50 Enzyme Immunoassay calibrators and controls contain 0, 25, 37.5, 50, 62.5, 75, and 100 ng/mL of 11-nor-A -THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These seven calibrators and controls are sold as individual bottles.
The LZI Cannabinoids (cTHC) 100 Enzyme Immunoassay calibrators and controls contain 0, 50, 75, 100, 125, 150, and 200 ng/mL of 11-nor-A -THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These thirteen calibrators and controls are sold as individual bottles.
The provided text is a 510(k) summary for the LZI Cannabinoids (cTHC) Enzyme Immunoassay, and it describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving performance.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics (like sensitivity, specificity, accuracy, or limits of detection) from a performance study. It states that the device is "identical or similar to their predicate in terms of ... clinical performance," implying that its performance is expected to meet similar standards as the previously cleared predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. A 510(k) summary often summarizes performance data but doesn't always include the granular details of study design, such as sample size of the test set or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text. For an immunoassay, the "ground truth" would typically be established by a more definitive confirmatory method (like GC/MS), not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
This is not applicable as the device is an in-vitro diagnostic (IVD) immunoassay, not an AI-powered diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an immunoassay. The device itself is an "algorithm" (the immunoassay process) that directly produces a result. Its performance is inherent to the assay and reagents. The "human-in-the-loop" aspect for this type of device refers to the clinical interpretation of the assay result, which the document explicitly states should be followed up by a confirmatory method and professional judgment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implicitly states the ground truth for confirming results: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography|mass spectrometry (GC|MS or LC|MS) is the preferred confirmatory method)." This indicates that the ground truth for performance studies would be established by these confirmatory methods.
8. The sample size for the training set
This information is not provided in the given text. For an immunoassay, the "training set" concept is less about machine learning data and more about assay development and optimization, but the specific numbers are not here.
9. How the ground truth for the training set was established
This information is not provided in the given text. Similar to point 7, it would likely involve confirmatory methods during assay development.
Summary of available information:
- Device Name: LZI Cannabinoids (cTHC) Enzyme Immunoassay, Calibrators and Controls
- Intended Use: Qualitative and semi-quantitative determination of Cannabinoids in human urine at cutoff values of 25, 50, or 100 ng/mL.
- Predicate Device: Lin-Zhi International, Inc. Cannabinoid (THC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (K021887 & K021449).
- Performance Claim: The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are "identical or similar to their predicate in terms of ... clinical performance." This is the basis for substantial equivalence.
- Ground Truth Method for Confirmation: Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS).
In conclusion, while the document confirms the device's intended use and substantial equivalence to a predicate, it lacks the specifics of detailed performance studies, sample sizes, and expert involvement that your questions are looking for. This level of detail is often found in the full 510(k) submission, not just the publicly available summary.
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K110239
JUN 2 3 2011
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety 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. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax: e-mail: bclin@lin-zhi.com
Contact: Bernice Lin, Ph.D. VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, CannabinoidsClass II, L (91 Toxicology),21 CFR 862.3870 |
|---|---|
| Cannabinoids Calibrators,Class II, DLJ (91 Toxicology),21 CFR 862.3200 | |
| Cannabinoids Controls,Class 1, LAS (91 Toxicology),21 CFR 862.3280 | |
| Common Name: | Homogeneous Cannabinoids Enzyme Immunoassay |
| Proprietary Name: | LZI Cannabinoids (cTHC) Enzyme Immunoassay, |
| LZI Cannabinoids (cTHC) Drugs of Abuse (DAU)Calibrators | |
| LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) |
Controls
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Legally Marketed Predicate Device(s)
The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays (ElAs) are substantially equivalent to the Lin-Zhi International, Inc. Cannabinoid (THC) Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (K021887 & K021449) manufactured by Lin-Zhi International, Inc. The LZI Cannabinoids (cTHC) 25, 50, and Enzyme Immunoassays are identical or similar to their predicate in terms of 100 intended use, method principle, device components, and clinical performance.
Device Description
The LZI Cannabinoids (cTHC) 25, 50, and 100 assays are a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assays are based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cannabinoid derivative -labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound cannabinoid derivative - labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are kits comprised of two reagents, an R1 and R2 which are bottled separately but sold together within each kit.
The R1 solution contains a mouse monoclonal anti-cannabinoid antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with a cannabinoid derivative in buffer with sodium azide (0.09%) as preservative.
The LZI Cannabinoids (cTHC) 25 Enzyme Immunoassay calibrators and controls contain 0, 12.5, 18.75, 25, 31.25, 37.5, and 50 ng/mL of 11-nor-a3-THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These seven calibrators and controls are sold as individual bottles.
The LZI Cannabinoids (cTHC) 50 Enzyme Immunoassay calibrators and controls contain 0, 25, 37.5, 50, 62.5, 75, and 100 ng/mL of 11-nor-A -THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These seven calibrators and controls are sold as individual bottles.
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The LZI Cannabinoids (cTHC) 100 Enzyme Immunoassay calibrators and controls contain 0, 50, 75, 100, 125, 150, and 200 ng/mL of 11-nor-A -THC-9-COOH in human urine with sodium azide (0.09%) as preservative. These thirteen calibrators and controls are sold as individual bottles.
Intended Use
The LZI Cannabinoids (cTHC) 25, 50, and 100 Enzyme Immunoassays are intended for the qualitative and semi-quantitative determination of Cannabinoids in human urine using 11-nor-A -THC-9-COOH (the major metabolite of THC referred to here as cTHC) as calibrator at the cutoff values of 25, 50, or 100 ng/mL. The assays are designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures.
The LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Cannabinoids (cTHC) Enzyme Immunoassay.
The LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Cannabinoids (cTHC) Enzyme Immunoassay,
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography|mass spectrometry (GC|MS or LC|MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design incorporated into it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Lin-Zhi International Inc. c/o Ms. Bernice Lin Vice President Operations 670 Almanor Avenue Sunnyvale, CA 94085-2917
JUL 27 2011
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
K110239 Re:
Trade Name: LZI Cannabinoids (cTHC) Enzyme Immunoassay, LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Calibrator, LZI Cannabinoids (cTHC) Drugs of Abuse (DAU) Controls Regulation Number: 21 CFR § 862.3870 Regulation Name: Cannabinoid Test System. Regulatory Class: Class II Product Codes: LDJ, DLJ, LAS Dated: June 08, 2011 Received: June 08, 2011
Dear Ms. Lin:
This letter corrects our substantially equivalent letter of June 23, 2011.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Signature
Courtney C. Harper, Ph.D. 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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Premarket Notification
Indications for Use Statement
510(k) Number (if known): K110239
Device Name: Cannabinoids (cTHC) Enzyme Immunoassay Cannabinoids (cTHC) Calibrators and Controls
Indications for Use:
The LZI Cannabinoids (cTHC) Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Cannabinoids in human urine using 11-nor-ШУ-ТНС-9-COOH (the major metabolite of THC referred to here as cTHC) as calibrator at the cutoff values of 25, 50, or 100 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for the purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC/MS or (2) permitting laboratories to establish quality control procedures. The Cannabinoids (cTHC) Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Cannabinoids (cTHC) Enzyme Immunoassay.
The Cannabinoids (cTHC) Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Cannabinoids (cTHC) Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Per 21 CFR 801.109)
Carl
Division Sian-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1
§ 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).