The Cannabinoid Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

The Cannabinoid Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

Device Description

All of the Cannabinoid Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. They each contain a known concentration of 11-nor-A -THC-9-Carboxylic Acid.

All of the Cannabinoid Urine DAU Calibrators and Controls are prepared by spiking known concentrations of 11-nor-A -THC-9-Carboxylic Acid into the Negative DAU Calibrator. which is a processed, drug-free human urine-based matrix. The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lin-Zhi International, Inc. Cannabinoid Urine Drugs of Abuse Calibrators and Controls:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a full-scale clinical trial. Therefore, much of the requested information (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance studies, and detailed ground truth for training sets) is not applicable or not provided in this type of submission.

The "study" undertaken here is essentially a comparison study to the predicate device to demonstrate similar performance characteristics.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the new device performs similarly to the predicate device in key areas like precision, accuracy, and stability, using established methods (GC/MS for nominal concentrations). The FDA's acceptance is based on the claim of substantial equivalence.

Acceptance Criteria (Implied by Equivalence Claim)	Reported Device Performance (as claimed by manufacturer)
Intended Use Equivalence:	Similar intended use: calibration and validation of Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.
Matrix Type:	Both are urine-based liquids.
Analyte Identification:	Both contain 11-nor-A-THC-9-Carboxylic Acid.
Concentration Determination:	Nominal concentrations determined and confirmed by GC/MS (stated for both predicate and new device).
Cut-off Concentration(s):	Same cut-off concentrations, including the 50 ng/mL SAMHSA recommendation.
Storage Conditions:	Same storage condition: 2℃ to 8℃.
Performance Characteristics (General):	Performance characteristics on precision, accuracy, and stability are similar (stated for both predicate and new device). Specific quantitative data not provided in summary.

Additional Information based on the 510(k) Summary

Sample size used for the test set and the data provenance:
- Not explicitly provided in this 510(k) summary. A 510(k) summary typically doesn't detail the specific sample sizes of the internal verification and validation studies. The studies are assumed to be internal to the manufacturer for demonstrating performance characteristics like precision, accuracy, and stability, with results compared to the predicate.
- Data provenance: Not specified, but generally, such studies are conducted by the manufacturer in a laboratory setting. Prospective or retrospective is not relevant as it's not a clinical study on human subjects in the usual sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The "ground truth" for calibrators and controls is established by precise chemical methods (GC/MS in this case) to determine the exact concentration of the analyte, not by expert interpretation. Experts are not typically involved in establishing the ground truth for these types of in vitro diagnostic devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for these chemical calibrators and controls.
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 device is a chemical calibrator/control, not an AI-powered diagnostic system or a device for human reader interpretation. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the context of AI algorithms. However, if interpreted as "device performance on its own," the underlying performance of precision, accuracy, and stability would have been evaluated in a standalone manner by the manufacturer, but the details are not provided in this summary. The device's "performance" is its ability to provide known, accurate concentrations for calibration and control.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Chemical/Quantitative Measurement. The "ground truth" for the concentration of 11-nor-A-THC-9-Carboxylic Acid in the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a highly accurate analytical chemistry technique.
The sample size for the training set:
- Not applicable/Not provided. This is not an AI-driven device that requires a training set in the machine learning sense. The device is a chemical reagent.
How the ground truth for the training set was established:
- Not applicable. As above, no training set in the machine learning sense. The concentrations are established by precise chemical methods (GC/MS).

Summary

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KO21449

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. 2391 Zanker Road, Suite 340 San Jose, CA 95131 Phone: (408) 944-0360 (408) 944-0359 Fax:

Chiu Chin Chang, Ph.D. Contact: VP, R&D

Device Name and Classification

(a) Classification Name:	Calibrators, Drug Specific;Class II, DLJ (91 Toxicology), 21 CFR 862.3200
Common/Usual Name:	Cannabinoid Calibrators
Proprietary Name:	None
(b) Classification Name:	Drug Specific Control Materials;Class I, LAS (91 Toxicology), 21 CFR 862.3280
Common/Usual Name:	Cannabinoid Controls
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.' Cannabinoid Urine Drugs of Abuse (DAU) Calibrators and Controls are substantially equivalent to the A-Cannabinoid (THC) Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications K923386 and 932113.

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Device Description

ﺮﮮ ﮐﮯ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔

Intended Use

The Cannabinoid Urine DAU Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

The Cannabinoid Urine DAU Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

Comparison to Predicate Device

LZI's Cannabinoid Urine DAU Calibrators and Controls are similar in intended use, matrix. and performance to the DRI's A -Cannabinoid (THC) Urine Calibrators and Controls.

Similarities:

Both are for the calibration and validation of Cannabinoid Enzyme Immunoassav to detect cannabinoids (THC) in human urine.

The cutoff concentration(s) for the analyte are the same. which include the cutoff of 50 . ng/mL per recommendation of The Substance Abuse and Mental Health Services Administration (SAMHSA) for the initial screening test of cannabinoids (THC) abuse. The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed bv GC/MS.
. Both are urine-based liquids. Storage condition is the same, at 2℃ to 8℃. Performance characteristics on precision, accuracy and stability are similar.

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Comparison to Predicate Device (continued)

Differences:

Characteristics	DRI's Δ9-Cannabinoid(THC) UrineCalibrators and Controls	LZI's Cannabinoid UrineDAU Calibrators and Controls
No. of Calibrators	5 levels including theNegative Calibrator.	A total of 9 levels includingthe Negative Calibrator areavailable.
No. of Controls	4 levels of controls available	2 levels of controls for eachcutoff assay.
Concentration ofAnalyte	0, 20, 40, 50, 60, 75, 100,125, and 200 ng/mL	0, 10, 20, 30, 37.5, 50, 62.5,75, 100, 125, 150, and 200ng/mL

Conclusion

The information provided in the premarket notification demonstrates that the LZI's Cannabinoid Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to previously approved predicate devices, notably the DRI's A -Cannabinoid (THC) Urine Calibrators and Controls, and safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." are arranged in a circle around the eagle image.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 8 2002

Chiu Chin Chang, Ph.D. VP. R&D Lin-Zhi International. Inc. 2391 Zanker Road, Suite 340 San Jose. CA 95131

Re: K021449

Trade/Device Name: Cannabinoid Urine Drugs of Abuse Calibrators and Controls Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator Regulatory Class: Class II Product Code: DLJ Dated: April 29, 2002 Received: May 6, 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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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 1 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/dsmamain.html".

Sincerely yours,

Steven Butman

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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Premarket Notification

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Cannabinoid Urine Drugs of Abuse Calibrators and Controls

Indications for Use:

The Cannabinoid Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

The Cannabinoid Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.

Jean

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021449

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)

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.