(118 days)
None
No
The description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML.
No
The device is an immunoassay for detecting amphetamines in urine, providing preliminary analytical results for diagnostic purposes, not for treating a condition.
Yes
This device performs qualitative and semi-quantitative analyses of amphetamines in human urine to provide a preliminary analytical test result regarding drug presence. This falls under the definition of a diagnostic device as it is used to identify the presence of a specific substance in a biological sample, which can aid in clinical diagnosis.
No
The device description clearly indicates it is a "ready-to-use, liquid reagent, homogeneous enzyme immunoassay" which is a chemical assay, not a software-only device. It involves chemical reactions and spectrophotometric measurements.
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 semi-quantitative analyses of amphetamines in human urine." This indicates that the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting amphetamines).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses "specific antibody" to detect substances in "human urine." This aligns with the definition of an in vitro diagnostic test.
- Performance Studies: The document describes performance characteristics like accuracy, sensitivity, and specificity, which are typical evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K934891; Amphetamines Enzyme Immunoassay) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
The analysis of substances in human specimens outside of the body for diagnostic or other medical purposes is the core function of an IVD, and this device fits that description perfectly.
N/A
Intended Use / Indications for Use
The Amphetamines Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of amphetamines in human urine.
Product codes
DKZ
Device Description
L.ZI's Amphetamines Enzyme Immunoassay is a ready-to-use, liguid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect amphetamine and/or methamphetamine in human urine with minimal cross-reactivity to other drugs of abuse, and common prescription drugs.
The assay is based on competition between amphetamines labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme, and free drugs from the urine sample for a fixed amount of specific antibody mixtures. In the absence of free drugs from the urine sample the specific antibodies bind to the drugs 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 convert 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity.
Performance Characteristics:
Within Run Precision (Qualitative):
Negative: Mean Rate 273.0, SD 0.95, % CV 0.35
750 ng/mL: Mean Rate 390.0, SD 1.45, % CV 0.37
1000 ng/mL: Mean Rate 415.7, SD 1.41, % CV 0.34
1250 ng/mL: Mean Rate 439.0, SD 1.63, % CV 0.37
2000 ng/mL: Mean Rate 480.5, SD 1.42, % CV 0.30
Within Run Precision (Semi-quantitative):
750 ng/mL: Mean Recovery 751.1, SD 9.83, % CV 1.31
1000 ng/mL: Mean Recovery 1008.6, SD 14.02, % CV 1.39
1250 ng/mL: Mean Recovery 1249.6, SD 17.24, % CV 1.38
Run-To-Run Precision (Qualitative):
Negative: Mean Rate 272.9, SD 2.28, % CV 0.84
750 ng/mL: Mean Rate 390.5, SD 2.88, % CV 0.74
1000 ng/mL: Mean Rate 415.9, SD 3.04, % CV 0.73
1250 ng/mL: Mean Rate 439.1, SD 3.60, % CV 0.82
2000 ng/mL: Mean Rate 479.6, SD 3.47, % CV 0.72
Run-To-Run Precision (Semi-quantitative):
750 ng/mL: Mean Recovery 756.6, SD 14.81, % CV 1.96
1000 ng/mL: Mean Recovery 997.7, SD 25.01, % CV 2.51
1250 ng/mL: Mean Recovery 1265.2, SD 29.54, % CV 2.33
Accuracy: Vs. DRI's Amphetamines EIA (n = 218)
Positive Samples: 100 % agreement
Negative Samples: 100 % agreement
Analytical Recovery:
Qualitative: 100 % accurate on positive vs. negative tests
Semi-quantitative: Quantitative within 10% of the nominal concentration between 300 ng/mL and 1900 ng/mL. 104.2 % recovery at 750 ng/mL level (Cutoff - 25%). 101.2 % recovery at 1250 ng/mL level (Cutoff + 25%).
Specificity: Comparable to the predicate device.
All studies showed acceptable results when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 30 ng/mL
Specificity: Comparable to the predicate device.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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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JUN 0 4 2002
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 95131-1124 Phone: (408) 944-0360 Fax: (408) 944-0359
Chiu Chin Chang, Ph.D. Contact: VP. R&D
Device Name and Classification
| Classification Name: | Amphetamine test system, Class II, DKZ (91),
21 CFR 862.3100 |
|----------------------|------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous enzyme immunoassay for the determination
of amphetamines levels in urine. |
| Proprietary Name: | None |
Legally Marketed Predicate Device(s)
Lin-Zhi International, Inc.'s Amphetamines Enzyme Immunoassay is substantially equivalent to the Amphetamines Enzyme Immunoassay by Diagnostic Reagents Inc. (now Microgenics, Inc.), cleared under premarket notification K934891.
LZI's Amphetamines Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
L.ZI's Amphetamines Enzyme Immunoassay is a ready-to-use, liguid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect amphetamine and/or methamphetamine in human urine with minimal cross-reactivity to other drugs of abuse, and common prescription drugs.
1
The assay is based on competition between amphetamines labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme, and free drugs from the urine sample for a fixed amount of specific antibody mixtures. In the absence of free drugs from the urine sample the specific antibodies bind to the drugs 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 convert nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use
The Amphetamines Enzyme Immunoassav is a homogeneous enzyme innnunoassay with a 1000 ng/mL cutoff. The assav is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine.
Comparison to Predicate Device
LZI's Amphetamines 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 DRI's Amphetamines Enzyme Immunoassay (K934891).
The following table compares LZI's Amphetamines Enzyme Immunoassay with the predicate device, DRI's Amphetamines Enzyme Immunoassay:
Similarities:
- . Both assays are for qualitative and semi-quantitative determination of amphetamines in human urine.
- . Both assays use the same method principle, and device components.
- Both assay use 1000 ng/mL as cutoff level per recommendations of The . Substance Abuse and Metal Health Services Administration (SAMHSA).
Differences:
LZI's Amphetamines Enzyme Immunoassay uses 5 calibrators for the semiquantitative analysis of amphetamines in urine. DRI's Amphetamines ElA uses 3 calibrators for semi-quantitative purpose previously. Additional calibrators (to a total of 5 calibrators) are also available now.
2
(Comparison to Predicate Device, continued)
Performance Characteristics
| Feature | DRI's Amphetamines EIA | LZI's Amphetamines EIA | ||||||
|---|---|---|---|---|---|---|---|---|
| Within Run Precision: | ||||||||
| Qualitative: | Mean Rate | SD | % CV | Mean Rate | SD | % CV | ||
| Negative | 312 | 1 | - | Negative | 273.0 | 0.95 | 0.35 | |
| 750 ng/mL | 418 | 2 | - | 750 ng/mL | 390.0 | 1.45 | 0.37 | |
| 1000 ng/mL | 443 | 2 | - | 1000 ng/mL | 415.7 | 1.41 | 0.34 | |
| 1250 ng/mL | 468 | 2 | - | 1250 ng/mL | 439.0 | 1.63 | 0.37 | |
| 2000 ng/mL | 513 | 3 | - | 2000 ng/mL | 480.5 | 1.42 | 0.30 | |
| Semi-quantitative: | No data available | Mean Recovery | SD | % CV | ||||
| 750 ng/mL | 751.1 | 9.83 | 1.31 | |||||
| 1000 ng/mL | 1008.6 | 14.02 | 1.39 | |||||
| 1250 ng/mL | 1249.6 | 17.24 | 1.38 | |||||
| Run-To-Run Precision: | ||||||||
| Qualitative: | No data available | Mean Rate | SD | % CV | ||||
| Negative | 272.9 | 2.28 | 0.84 | |||||
| 750 ng/mL | 390.5 | 2.88 | 0.74 | |||||
| 1000 ng/mL | 415.9 | 3.04 | 0.73 | |||||
| 1250 ng/mL | 439.1 | 3.60 | 0.82 | |||||
| 2000 ng/mL | 479.6 | 3.47 | 0.72 | |||||
| Semi-quantitative: | No data available | Mean Recovery | SD | % CV | ||||
| 750 ng/mL | 756.6 | 14.81 | 1.96 | |||||
| 1000 ng/mL | 997.7 | 25.01 | 2.51 | |||||
| 1250 ng/mL | 1265.2 | 29.54 | 2.33 | |||||
| Sensitivity: | 10 ng/mL | 30 ng/mL | ||||||
| Accuracy: | Vs. a commercially available EIA | (1) Vs. DRI's Amphetamines EIA (n = 218) | ||||||
| Positive Samples: | 100 % agreement | 100 % agreement | ||||||
| Negative Samples: | 100 % agreement | 100 % agreement | ||||||
| Analytical Recovery: | ||||||||
| Qualitative: No data available | 100 % accurate on positive vs. negative tests | |||||||
| Semi-quantitative: No data available | Quantitate within 10% of the nominal | |||||||
| concentration between 300 ng/mL and 1900 | ||||||||
| ng/mL | ||||||||
| 104.2 % recovery at 750 ng/mL level (Cutoff - | ||||||||
| 25%) | ||||||||
| 101.2 % recovery at 1250 ng/mL level (Cutoff + | ||||||||
| 25%) | ||||||||
| Specificity: | See attached DRI's Amphetamines EIA | |||||||
| package insert | Comparable to the predicate device. | |||||||
3
Conclusion
LZI's Amphetamines 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 Amphetamines Enzyme Immunoassay to other amphetamine test systems currently marketed in the United States.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines underneath them, resembling water or fabric.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 0 4 2002
Chiu Chin Chang, Ph.D. VP. R&D Lin-Zhi International. Inc. 2391 Zanker Road, Suite 340 San Jose. CA 95131-1124
Re: K020395
Trade/Device Name: Amphetamines Enzyme Immunoassay Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: April 24, 2002 Received: April 26, 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. Iisting 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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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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
6
Premarket Notification
Indications for Use Statement
510(k) Number (if known): Kozo395
Device Name: Amphetamines Enzyme Immunoassav
Indications for Use:
The Amphetamines Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of amphetamines in human urine.
The Amphetamines 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-ofabuse test result, particularly when preliminary positive results are used.
teun Cooger
(Division Sign-Off)
Division of Clinical Laboratory L
510(k) Number K020395
Concurrence of CDRH, Office of Device Evaluation (ODE)
j
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)