(43 days)
K923386, 932113
Not Found
No
The device description and intended use clearly define the product as calibrators and controls for a specific immunoassay, which are chemical reagents and do not involve AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
This device is for in vitro diagnostic use, intended for calibrating and validating tests to detect cannabinoids in human urine. It is not used to treat, diagnose, or prevent disease in a patient.
No
Explanation: The device is described as calibrators and controls for an immunoassay, not the immunoassay itself. Calibrators and controls are used to validate and calibrate diagnostic tests, rather than directly diagnosing conditions.
No
The device is described as liquid, human urine-based calibrators and controls, which are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: Both the Calibrators and Controls explicitly state they are "intended for in vitro diagnostic use".
- Purpose: They are used to calibrate and validate an enzyme immunoassay, which is a diagnostic test performed outside the body (in vitro) on a human sample (urine) to detect a substance (cannabinoids/THC).
- Device Description: The description confirms they are used in conjunction with a diagnostic test (Cannabinoid Enzyme Immunoassay) and are applied to a human sample (urine).
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DLJ, LAS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K923386, 932113
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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۔
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.
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) Urine
Calibrators and Controls | LZI's Cannabinoid Urine
DAU Calibrators and Controls |
|-----------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|
| No. of Calibrators | 5 levels including the
Negative Calibrator. | A total of 9 levels including
the Negative Calibrator are
available. |
| No. of Controls | 4 levels of controls available | 2 levels of controls for each
cutoff assay. |
| Concentration of
Analyte | 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 200
ng/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.
3
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.
4
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 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
5
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)