(88 days)
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No
The description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric analysis, with no mention of AI or ML components.
No.
The device is an in vitro diagnostic (IVD) test intended for the qualitative and semi-quantitative analysis of oxycodone and its metabolite in human urine, providing a preliminary analytical test result for drug-of-abuse testing, not for treating a disease or condition.
Yes
Explanation: The device is an immunoassay intended for analyzing oxycodone and its metabolite in human urine, which provides preliminary analytical test results for a specific substance. This falls under the definition of a diagnostic device as it is used to identify or measure a condition or substance related to a medical state.
No
The device is a homogeneous enzyme immunoassay, which is a laboratory test involving chemical reagents and reactions, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the analysis of oxycodone and its metabolite in human urine. This is a biological sample taken from the human body.
- Device Description: The description details a laboratory test that uses reagents and measures enzyme activity in a sample to detect the presence of a substance. This is characteristic of an in vitro diagnostic test.
- Anatomical Site: The specified anatomical site is "human urine," which is a sample collected from a human.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device is for drug testing, drug testing in a clinical context falls under the umbrella of IVD as it provides information about a person's health status or exposure to substances that can impact health.
N/A
Intended Use / Indications for Use
The LZI Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of oxycodone and its metabolite in human urine. The LZI Oxycodone 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 judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
The Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 ng/mL and 300 ng/mL cutoffs. Intended for use in the qualitative and semi-qualitative and semi-quantitative analyses of Oxycodone and its metabolite, oxymorphone in human urine. The Oxycodone calibrators are used to calibrate the oxycodone enzyme immunoassay for the assay. The Oxycodone controls are used to validate the assay. The assay provides a simple and rapid analytical screening procedure to detect oxycodone and its metabolite in human urine. The test is to be used in conjunction with automated clinical chemistry analyzers. Performance data submitted was obtained using the Hitachi 717 analyzer. The Oxycodone 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 judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
Device Description
LZI's Oxycodone Enzyme Immunoassay is a ready-to-use liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect oxycodone and oxymophone in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between oxycodone derivative labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme and free drug from sample for a fixed amount of specific antibody. In the absence of free drug from the 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 mm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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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.)
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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.
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.
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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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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).
0
050733
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. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849
Cheng-I Lin, Ph.D. Contact: President, R&D Director
Device Name and Classification
| Classification Name: Enzyme Immunoassay, Opiate
Class II, DJG (91 Toxicology),
| 21CFR 862.3650 |
|---|
| Oxycodone calibrators, |
| Class II, DLJ, (91 Toxicology), |
| 21CFR 862.3200 |
Oxycodone controls, Class I, LAS (91 Toxicology), 21CFR 862.3280
| Common Name: | Homogeneous Oxycodone Enzyme Immunoassay |
|---|---|
| Proprietary Name: | LZI Oxycodone Assay |
Legally Marketed Predicate Device(s)
The LZI Oxycodone Enzyme Immunoassay is substantially equivalent to the DRI® Oxycodone Assay (K040411) manufactured by DRI/Microgenics Corp.
LZI's Oxycodone Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
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Device Description
LZI's Oxycodone Enzyme Immunoassay is a ready-to-use liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect oxycodone and oxymophone in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between oxycodone derivative labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme and free drug from sample for a fixed amount of specific antibody. In the absence of free drug from the 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 mm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The LZI Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of oxycodone and its metabolite in human urine. The LZI Oxycodone 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 judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Comparison to Predicate Device
LZI's Oxycodone Enzyme Immunoassay is substantially equivalent to the product in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed DRI® Oxycodone Assay (K040411) by Microgenics Corporation.
The following table compares LZI's Oxycodone Enzyme Immunoassay with the predicate device, DRI Oxycodone Enzyme Immunoassay by Microgenics Corp.
Similarities:
- Both assays are for qualitative and semi-quantitative determination of oxycodone . and its metabolite in human urine.
- Both are ready-to-use liquid reagents. .
- Both have 100 and 300 ng/mL cutoffs. .
- Both assays use the same method principle, and device components. .
- Both stored at 2℃ to 8℃ until expiration date. .
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Differences:
- DRI assay uses 5 points calibration (0, 100, 300, 500, 1000 ng/ml) for semi-. quantitative determination. LZI assay uses three different calibrator/control sets (0, 75, 100, 225, and 300 ng/mL) (0, 100, 300, 500 and 800 ng/mL) for semiquantitative determination.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2005
Cheng-I Lin, Ph.D. President Lin-Zhi International, Inc. 687 North Pastoria Ave Sunnyvale, CA 94085
Re: K050733
Trade/Device Name: Oxycodone Enzyme Immunoassay and Oxyodone Calibrators and Controls Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DLJ, LAS Dated: May 20, 2005 Received: May 24, 2005
Dear Dr. Lin:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to oogin manteenig your device of your device to a legally premarket notification: - The PDT Intactig sification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific infortion and advertising of your device, please contact the Office of In of questions on the premier Evaluation and Safety at (240) 276-0484. Also, please note the v mo Diagnostic Develop Branding by reference to premarket notification" (21CFR Part 807.97). regulation ontaou, "Thiordians" of stimment on your responsibilities under the Act from the I va may other 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/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting 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): __ K050733
Device Name: Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls.
Indications for Use:
The Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 The Oxyodone Enzynie Intended for use in the qualitative and semi-qualitative and semi-quantitative and 500 ing mill outone and its metabolite, oxymorphone in human urine.
analyses of Uxyoodone ans are used to calibrate the oxycodone enzyme immunoassay for I he Oxyoodone canorators are The Oxycodone controls are used to validate the assay. the assay provides a simple and rapid analytical screening procedure to detect oxycodone and its metabolite in human urine.
allo its nictaoonie in haman anner of automated clinical chemated clinical chemistry analyzers. Performance data submitted was obtained using the Hitachi 717 analyzer. analyzers: Forformance ammunoassay provides only a preliminary analytical test result. A The Oxyoodene Lingine chemical method must be used to obtain a confirmed analytical more specific atchiatry of themass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.
V Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
Qute a Chele (Per 21 CFR 801.109)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K050733