(122 days)
Not Found
No
The device description and performance studies focus on a standard enzyme immunoassay method, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) test intended for the qualitative and semiquantitative analysis of Methadone Metabolite in human urine, used to provide a preliminary analytical test result. It does not treat or alleviate a disease, injury, or condition in a patient.
Yes
The device is intended for the qualitative and semiquantitative analyses of Methadone Metabolite in human urine, providing preliminary analytical test results to inform and aid in diagnosis.
No
The device is a homogeneous enzyme immunoassay, which is a chemical reagent-based test, not a software-only device. It is intended for use with automated clinical chemistry analyzers, which are hardware devices.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for use in the qualitative and semiquantitative analyses of Methadone Metabolite in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (presence of Methadone Metabolite).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses "human urine" as the sample. This confirms the in vitro nature of the test.
- Anatomical Site: The specified anatomical site is "human urine," which is a biological sample taken from the body for analysis.
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Methadone Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of Methadone Metabolite in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Metabolite 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 (comma separated list FDA assigned to the subject device)
DJR; DLJ
Device Description
LZI's Methadone Metabolite Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect Methadone Metabolite (EDDP) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between Methadone Metabolite labeled with glucose-6phosphate 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 covert nicotinamide adenine dinucleotide (NAD) to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
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)
Performance characteristics evaluated include precision, sensitivity, accuracy, analytical recovery, and specificity.
Within Run Precision (Qualitative):
Negative: Mean Rate 297.9, SD 2.16, % CV 0.73
225 ng/mL: Mean Rate 354.0, SD 2.43, % CV 0.69
300 ng/mL: Mean Rate 379.4, SD 2.69, % CV 0.72
375 ng/mL: Mean Rate 390.9, SD 3.03, % CV 0.78
1000 ng/mL: Mean Rate 449.4, SD 3.37, % CV 0.75
Within Run Precision (Semi-quantitative):
225 ng/mL: Mean Conc. 227.9, SD 8.84, % CV 3.88
300 ng/mL: Mean Conc. 304.9, SD 13.73, % CV 4.50
375 ng/mL: Mean Conc. 382.8, SD 13.0, % CV 3.40
Run-To-Run Precision (Qualitative):
Negative: Mean Rate 296.7, SD 2.2, % CV 0.74
225 ng/mL: Mean Rate 357.3, SD 2.9, % CV 0.81
300 ng/mL: Mean Rate 377.2, SD 1.8, % CV 0.47
375 ng/mL: Mean Rate 390.6, SD 2.5, % CV 0.63
1000 ng/mL: Mean Rate 452.5, SD 4.2, % CV 0.93
Run-To-Run Precision (Semi-quantitative):
225 ng/mL: Mean Conc. 227.2, SD 8.17, % CV 3.59
300 ng/mL: Mean Conc. 298.4, SD 10.8, % CV 3.62
375 ng/mL: Mean Conc. 371.1, SD 11.8, % CV 3.19
Sensitivity: 15 ng/mL
Accuracy: Vs. GC/MS (n=139)
Positive Samples: 100 % agreement
Negative Samples: 100 % agreement
Analytical Recovery:
Qualitative: 100 % accuracy on positive vs. negative tests
Semi-quantitative: Quantitates within ±15% of the nominal concentration between 30 ng/mL and 900 ng/mL. Average 95.0 % recovery at 225 ng/mL level (Cutoff -25%). Average 105.4 % recovery at 375 ng/mL level (Cutoff + 25%).
All studies showed acceptable results when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 15 ng/mL
Accuracy: 100 % agreement for positive and negative samples vs. GC/MS.
Analytical Recovery: Average 95.0 % recovery at 225 ng/mL, Average 105.4 % recovery at 375 ng/mL.
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.
Not Found
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).
Not Found
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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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Image /page/0/Picture/1 description: The image shows the word "DEPARTMENT" in a bold, sans-serif font. The word is located at the top of the image and is horizontally oriented. There is a horizontal line below the word. The image is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1 2004
Cheng-I Lin, Ph.D. President Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085
Re: K031797
Trade/Device Name: Methadone Metabolite Enzyme Immunoassay Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR; DLJ Dated: August 25, 2003 Received: August 25, 2003
Dear Dr. Lin:
This SE Letter corrects the letter stamp dated October 10, 2003. The letter had only one Product Code. This letter corrects that with the addition of second Product Code DLJ.
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, Dr to 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, ist in o f 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 Begister.
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 aff 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) 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 the fire 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
OCT 1 0 2003
Image /page/2/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K031797'. The characters are written in a simple, slightly irregular style, giving them a casual appearance.
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 (408) 732-3849 Fax:
| Contact: | Cheng-I Lin, Ph.D. | ||||
|---|---|---|---|---|---|
| President, R&D Director |
Device Name and Classification
| Classification Name: | Methadone Metabolite test system, Class II, DJR (91 Toxicology), 21CFR 862.3620 |
|---|---|
| Common Name: | Homogeneous enzyme immunoassay for the determination of Methadone Metabolite (EDDP) levels in urine. |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.' Methadone Metabolite Enzyme Immunoassay is substantially equivalent to the Methadone Metabolite Enzyme Immunoassay (By DRI/Microgenics Corp.), cleared under premarket notification K931780.
LZI's Methadone Metabolite 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 Methadone Metabolite Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect Methadone Metabolite (EDDP) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
3
The assay is based on competition between Methadone Metabolite labeled with glucose-6phosphate 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 covert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Methadone Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of Methadone Metabolite in human urine.
Comparison to Predicate Device
LZI's Methadone Metabolite 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 Methadone Metabolite Enzyme Immunoassay (K931780) by DRI/Microgenics Corporation.
The following table compares LZI's Methadone Metabolite Enzyme Immunoassay with the predicate device, Methadone Metabolite Enzyme Immunoassay by DRI/Microgenics Corp.
Similarities:
- . Both assays are for qualitative and semi-quantitative determination of Methadone Metabolite in human urine.
- Both assays use the same method principle, and device components. .
Differences:
- DRI/Microgenics assay uses 4 points calibration (0. 300, 1000, 2000 ng/ml) for . semi-quantitative determination. LZI assay uses 5 calibrator set (0, 150, 300, 600, and 1000 ng/ml) for semi-quantitative determination.
- LZI assay uses 300 ng/ml calibrator as cut-off concentration. DRI/Microgenics ● assay uses 1000 ng/ml calibrator as cut-off concentration.
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(Comparison to Predicate Device, continued)
Performance Characteristics
| Feature | DRI's Methadone Metabolite EIA | LZI's Methadone Metabolite EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | ||||||||
| Qualitative: | Mean Rate | SD | % CV | Mean Rate | SD | % CV | ||
| Negative | 620 | 4.1 | 0.7 | Negative | 297.9 | 2.16 | 0.73 | |
| 300 ng/mL | 776 | 4.4 | 0.6 | 225 ng/mL | 354.0 | 2.43 | 0.69 | |
| 1000 ng/mL | 974 | 7.7 | 0.8 | 300 ng/mL | 379.4 | 2.69 | 0.72 | |
| 2000 ng/mL | 1083 | 5.4 | 0.5 | 375 ng/mL | 390.9 | 3.03 | 0.78 | |
| 1000 ng/mL | 449.4 | 3.37 | 0.75 | |||||
| Semi-quantitative: No data available | Mean Conc. | SD | % CV | |||||
| 225 ng/mL | 227.9 | 8.84 | 3.88 | |||||
| 300 ng/mL | 304.9 | 13.73 | 4.50 | |||||
| 375 ng/mL | 382.8 | 13.0 | 3.40 | |||||
| Run-To-Run Precision: | ||||||||
| Qualitative: No data available | Mean Rate | SD | % CV | |||||
| Negative | 296.7 | 2.2 | 0.74 | |||||
| 225 ng/mL | 357.3 | 2.9 | 0.81 | |||||
| 300 ng/mL | 377.2 | 1.8 | 0.47 | |||||
| 375 ng/mL | 390.6 | 2.5 | 0.63 | |||||
| 1000 ng/mL | 452.5 | 4.2 | 0.93 | |||||
| Semi-quantitative: No data available | Mean Conc. | SD | % CV | |||||
| 225 ng/mL | 227.2 | 8.17 | 3.59 | |||||
| 300 ng/mL | 298.4 | 10.8 | 3.62 | |||||
| 375 ng/mL | 371.1 | 11.8 | 3.19 | |||||
| Sensitivity: | 75 ng/mL | 15 ng/mL | ||||||
| Accuracy: | Vs. a commercial EIA | Vs. GC/MS (n=139) | ||||||
| Positive Samples: | 100 % agreement (GC/MS confirmed) | 100 % agreement | ||||||
| Negative Samples: | 100 % agreement | 100 % agreement | ||||||
| Analytical Recovery: | ||||||||
| Qualitative: No data available | 100 % accuracy on positive vs. negative tests | |||||||
| Semi-quantitative: No data available | Quantitates within ±15% of the nominal | |||||||
| concentration between 30 ng/mL and 900 ng/mL. | ||||||||
| Average 95.0 % recovery at 225 ng/mL level | ||||||||
| (Cutoff -25%) | ||||||||
| Average 105.4 % recovery at 375 ng/mL | ||||||||
| level (Cutoff + 25%) | ||||||||
| Specificity: | See attached DRI's Methadone | |||||||
| Metabolite EIA package insert | Comparable to the predicate device. |
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Conclusion
LZI's Methadone Metabolite 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 Methadone Metabolite Enzyme Immunoassay to other Methadone Metabolite test systems currently marketed in the United States.
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Premarket Notification
Indications for Use Statement
510(k) Number (if known): ΚΟ3 1797
Device Name: Methadone Metabolite Enzyme Immunoassay
Indications for Use:
The Methadone Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of Methadone Metabolite in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Metabolite 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.
Alberto C.
Division Sign-Off for Jean Carrier
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k). K031797
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)