(145 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) test intended for the qualitative and semi-quantitative determination of amphetamine and methamphetamine in human urine, which is used for diagnostic purposes, not for treating or preventing disease.
Yes
The device is an Enzyme Immunoassay intended for the qualitative and semi-quantitative determination of amphetamine and methamphetamine in human urine, providing a preliminary analytical result for drug detection. This falls under diagnostic testing as it aims to identify the presence and approximate quantity of substances in the body for clinical assessment.
No
The device is a laboratory immunoassay kit consisting of chemical reagents (R1 and R2 solutions) and calibrators/controls. It is designed for use with automated clinical chemistry analyzers, which are hardware devices. The description focuses on the chemical reactions and components of the assay, not on software functionality as the primary or sole component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative and semi-quantitative determination of amphetamine and methamphetamine in human urine." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (human urine) outside of the body to provide information about a medical condition or state (presence of amphetamines).
- Device Description: The description details a laboratory assay (enzyme immunoassay) that uses reagents to analyze a sample. This is consistent with the nature of IVD devices.
- Professional Use: The intended user is stated as "professional use," which aligns with the typical use of IVD devices in clinical laboratories or healthcare settings.
- Calibrators and Controls: The inclusion of calibrators and controls is standard practice for IVD assays to ensure accuracy and quality control.
- Performance Studies: The document describes performance studies (precision, limit of detection, linearity, method comparison, interference, specificity) which are required for the validation and regulatory approval of IVD devices.
- Predicate Device: The mention of a predicate device (K020395; Lin-Zhi International, Inc. Amphetamines Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems) further confirms that this device falls within the category of IVDs, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
The fact that it provides a "preliminary analytical result" and requires confirmation by a more specific method (GC/MS or LC/MS) is also common for screening IVD tests for drugs of abuse.
N/A
Intended Use / Indications for Use
The LZI Amphetamines 500 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of amphetamine and methamphetamine in human urine, at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Amphetamines Enzyme Immunoassay.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Amphetamines 500 Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DJC, DJC, DLJ, LAS
Device Description
The LZI Amphetamines 500 assay is a homogeneous enzyme immunoassay with readyto-use liguid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, amphetamines-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound amphetamines-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Amphetamines 500 Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The Ri solution contains two mouse monoclonal anti-amphetamines antibodies, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with amphetamines in buffer with sodium azide (0.09%) as preservative.
The LZI Amphetamines 500 Enzyme Immunoassay calibrators and controls contain 0, 250, 375, 500, 625, 1000, or 2000 ng/mL of d-methamphetamine in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
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
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)
Precision: The precision studies for d-methamphetamine and d-amphetamine were performed on the Hitachi 717 Analyzer.
For d-methamphetamine, the semi-quantitative precision was assessed across various concentrations (0 to 1000 ng/mL) with N=88. Within run %CV ranged from 2.2% to 116.6%, and total precision %CV ranged from 2.5% to 132.1%. For qualitative results at a 500 ng/mL cutoff, 22 determinations were made within run and 88 for total precision. At 0-375 ng/mL, all results were negative. At 500 ng/mL, 3 out of 22 were positive within run, and 18 out of 88 were positive for total precision. At 625-1000 ng/mL, all results were positive.
For d-amphetamine, the semi-quantitative precision was assessed across various concentrations (0 to 1000 ng/mL) with N=88. Within run %CV ranged from 1.7% to 77.6%, and total precision %CV ranged from 2.9% to 98.1%. For qualitative results at a 500 ng/mL cutoff, 22 determinations were made within run and 88 for total precision. At 0-375 ng/mL, all results were negative. At 500 ng/mL, all 22 within run results were positive, and 83 out of 88 total precision results were positive. At 625-1000 ng/mL, all results were positive.
Limit of Detection: The lowest concentration that can be differentiated from negative urine with 95% confidence is 50 ng/mL for both d-methamphetamine and d-amphetamine.
Linearity:
d-methamphetamine: Hitachi 717 Instrument: 0 - 2000 ng/mL. Regression equation: y = 0.9717x + 5.7341, r2 = 0.9971.
d-amphetamine: Hitachi 717 Instrument: 0 - 2000 ng/mL. Regression equation: y = 0.9447x + 24.34, r2 = 0.9978.
Method Comparison - Clinical Samples:
d-methamphetamine: From 86 clinical unaltered samples at a 500 ng/mL cutoff, there was 100% agreement with positive results and 67.4% agreement with negative samples for semi-quantitative data. For qualitative data, there was 100% agreement with positive results and 69.8% agreement with negative samples.
d-amphetamine: From 111 clinical unaltered samples at a 500 ng/mL cutoff, there was 97.8% agreement with positive results and 100% agreement with negative samples for semi-quantitative data. For qualitative data, there was 96.4% agreement with positive results and 100% agreement with negative samples.
Endogenous Compound Interference and Specificity - Cross-Reactivity: The assay showed cross-reactivity with PMA, MDA, MDMA, and MDEA. No significant undesired cross-reactants or endogenous substance interference were observed otherwise.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.3100 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).
0
510(k) Summary of Safety and Effectiveness
DEC 28 2010
==============================================================================================================================================================================
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. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax: e-mail: bclin@lin-zhi.com
Contact: Bernice Lin, Ph.D. VP Operations
Device Name and Classification
| Classification Name: | Enzyme Immunoassay, Amphetamines
Class II, DKZ (91 Toxicology),
21 CFR 862.3100 |
|----------------------|-------------------------------------------------------------------------------------------------|
| | Thin Layer Chromatography, Methamphetamine
Class II, DJC (91 Toxicology),
21 CFR 862.3610 |
| | Amphetamines Calibrators,
Class II, DLJ (91 Toxicology),
21 CFR 862.3200 |
| | Amphetamines Controls,
Class I, LAS (91 Toxicology),
21 CFR 862.3280 |
Common Name: Homogeneous Amphetamines Enzyme Immunoassay
LZI Amphetamines 500 Enzyme Immunoassay, Proprietary Name: LZI Amphetamines 500 Drugs of Abuse (DAU) Calibrators LZI Amphetamines 500 Drugs of Abuse (DAU) Controls
1
Legally Marketed Predicate Device(s)
The LZI Amphetamines 500 Enzyme Immunoassay (EIA) is substantially equivalent to the Lin-Zhi International, Inc. Amphetamines Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (K020395) manufactured by Lin-Zhi International, Inc. The LZI Amphetamines 500 Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.
Device Description
The LZI Amphetamines 500 assay is a homogeneous enzyme immunoassay with readyto-use liguid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, amphetamines-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound amphetamines-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Amphetamines 500 Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The Ri solution contains two mouse monoclonal anti-amphetamines antibodies, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with amphetamines in buffer with sodium azide (0.09%) as preservative.
The LZI Amphetamines 500 Enzyme Immunoassay calibrators and controls contain 0, 250, 375, 500, 625, 1000, or 2000 ng/mL of d-methamphetamine in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
2
Intended Use
The LZI Amphetamines 500 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of amphetamine and methamphetamine in human urine, at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Amphetamines Enzyme Immunoassay.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Amphetamines 500 Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
3
Comparison to Predicate Device
The LZI Amphetamines 500 Enzyme Immunoassay is substantially equivalent to the Lin-Zhi International, Inc. Amphetamines Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems cleared by the FDA under the premarket notification K020395 for its stated intended use.
The following table compares LZI's Amphetamines 500 Enzyme Immunoassay with the predicate device.
| Device
Characteristics | Subject Device (K102210)
LZI Amphetamines 500 Enzyme
Immunoassay | Predicate Device (K020395)
LZI Amphetamines Enzyme
Immunoassay |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LZI Amphetamines 500 Enzyme
Immunoassay, when used in conjunction
with Hitachi 717 automated clinical
system analyzers, is intended for the
qualitative and semi-quantitative
determination of amphetamine and
methamphetamine in human urine, at a
cutoff value of 500 ng/mL. The assay is
designed for professional use with a
number of automated clinical chemistry
analyzers.
This assay provides a rapid screening procedure
for determining the presence of Amphetamines in
urine. The assay provides only a preliminary
analytical result. A more specific alternative
chemical method must be used in order to obtain a
confirmed analytical result. Gas or liquid
chromatography/mass spectrometry (GC/MS or
LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. | The LZI Amphetamines Enzyme
Immunoassay, when used in conjunction
with Hitachi 717 automated clinical
system analyzers, is intended for the
qualitative and semi-quantitative
determination of Amphetamines in human
urine, at a cutoff value of 1000 ng/mL.
The assay is designed for professional use
with a number of automated clinical
chemistry analyzers.
This assay provides a rapid screening procedure
for determining the presence of Amphetamines in
urine. The assay provides only a preliminary
analytical result. A more specific alternative
chemical method must be used in order to obtain a
confirmed analytical result. Gas or liquid
chromatography/mass spectrometry (GC/MS or
LC/MS) is the preferred confirmatory method.
Clinical consideration and professional judgment
should be exercised with any drug of abuse test
result, particularly when the preliminary test result
is positive. |
| Analyte | d-methamphetamine and d-
amphetamine | Amphetamines |
| Cutoff | 500 ng/ml | 1000 ng/mL |
| Matrix | Urine | Urine |
| Calibrators
Level | 5 Levels
(0, 250, 500, 1000, 2000 ng/mL) | 5 Levels
(0, 500, 1000, 1500, 2000 ng/mL) |
| Controls Level | 2 Levels
(375 ng/mL, 625 ng/mL) | 2 Levels
(750 ng/mL, 1250 ng/mL) |
| Storage | 2-8 °C until expiration date | 2-8 °C until expiration date |
4
Performance Characteristics Summary:
Hitachi 717 Analyzer
Precision: d-methamphetamine
Precision: Semi-Quantitative, ng/mL
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (ng/mL) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 5.6 | 5.3 | 116.6 % | 5.6 | 7.5 | 132.1% |
| 125 ng/mL | 128.3 | 6.4 | 5.0 % | 128.3 | 8.4 | 6.6% |
| 250 ng/mL | 252.9 | 6.1 | 2.4 % | 252.9 | 9.1 | 3.6% |
| 375 ng/mL | 369.6 | 11.4 | 3.1 % | 369.6 | 14.6 | 4.0% |
| 500 ng/mL | 489.9 | 11.7 | 2.4 % | 489.9 | 15.9 | 3.2% |
| 625 ng/mL | 605.3 | 17.6 | 2.9 % | 605.3 | 19.3 | 3.2% |
| 750 ng/mL | 746.5 | 16.3 | 2.2 % | 746.5 | 18.9 | 2.5% |
| 875 ng/mL | 867.7 | 22.9 | 2.6 % | 867.7 | 25.6 | 3.0% |
| 1000 ng/mL | 1024.2 | 34.0 | 3.3 % | 1024.2 | 41.8 | 4.1% |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| N=88 | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| (ng/mL) | Mean | Qualitative Response | Mean | Qualitative Response | |
| 0 ng/mL | 5.6 | - | 5.6 | - | |
| 125 ng/mL | 128.3 | - | 128.3 | - | |
| 250 ng/mL | 252.9 | - | 252.9 | - | |
| 375 ng/mL | 369.6 | - | 369.6 | - | |
| 500 ng/mL | 489.9 | - | 489.9 | - | |
| 625 ng/mL | 605.3 | + | 605.3 | + | |
| 750 ng/mL | 746.5 | + | 746.5 | + | |
| 875 ng/mL | 867.7 | + | 867.7 | + | |
| 1000 ng/mL | 1024.2 | + | 1024.2 | + |
Semi-Quantitative Positive/Negative Results:
| 500 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| % of Cutoff | |||||
| Concentration | Number of | ||||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 125 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 250 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 375 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 500 ng/mL | 100.0% | 22 | 3 Pos/19 Neg | 88 | 18 Pos/70 Neg |
| 625 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 750 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 875 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
5
:
| N=88 | Within Run | Total Precision | ||||||
|---|---|---|---|---|---|---|---|---|
| (mA/min) | Mean | SD | % CV | Mean | SD | % CV | ||
| 0 ng/mL | 273.5 | 2.8 | 1.0 % | 273.5 | 3.4 | 1.2 % | ||
| 125 ng/mL | 314.5 | 2.2 | 0.7 % | 314.5 | 3.0 | 0.9 % | ||
| 250 ng/mL | 359.0 | 2.2 | 0.6 % | 359.0 | 3.4 | 0.9 % | ||
| 375 ng/mL | 398.2 | 3.0 | 0.8 % | 398.2 | 4.1 | 1.0 % | ||
| 500 ng/mL | 431.3 | 3.0 | 0.7 % | 431.3 | 4.3 | 1.0 % | ||
| 625 ng/mL | 459.6 | 3.8 | 0.8 % | 459.6 | 5.2 | 1.1 % | ||
| 750 ng/mL | 489.2 | 3.9 | 0.8 % | 489.2 | 5.4 | 1.1 % | ||
| 875 ng/mL | 509.7 | 4.1 | 0.8 % | 509.7 | 5.1 | 1.0 % | ||
| 1000 ng/mL | 533.1 | 3.7 | 0.7 % | 533.1 | 4.8 | 0.9 % |
Precision: Qualitative, mA/min
Qualitative Positive/Negative Results:
| 500 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 125 ng/ml | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 250 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 375 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 500 ng/mL | 100.0% | 22 | 13 Pos/9 Neg | 88 | 54Pos/34 Neg |
| 625 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 750 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 875 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
.
6
Performance Characteristics Summary: continued
Hitachi 717 Analyzer
Precision: d-amphetamine Precision: Semi-Quantitative, ng/mL
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (ng/mL) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 18.2 | 15.1 | 77.6% | 18.2 | 17.8 | 98.1% |
| 125 ng/mL | 165.5 | 10.1 | 6.1% | 165.5 | 14.3 | 8.6% |
| 250 ng/mL | 297.4 | 8.1 | 2.7% | 297.4 | 14.0 | 4.7% |
| 375 ng/mL | 409.0 | 8.2 | 2.0% | 409.0 | 15.7 | 3.8% |
| 500 ng/mL | 529.9 | 13.7 | 2.6% | 529.9 | 17.3 | 3.3% |
| 625 ng/mL | 631.3 | 10.6 | 1.7% | 631.3 | 18.5 | 2.9% |
| 750 ng/mL | 714.0 | 19.0 | 2.7% | 714.0 | 23.0 | 3.2% |
| 875 ng/mL | 809.1 | 15.4 | 1.9% | 809.1 | 20.7 | 2.6% |
| 1000 ng/mL | 910.6 | 20.2 | 2.2% | 910.6 | 26.6 | 2.9% |
Semi-Quantitative Precision Analysis Summary: Qualitative Results
| N=88 | Within Run | Total Precision | ||
|---|---|---|---|---|
| (ng/mL) | Mean | Qualitative Response | Mean | Qualitative Response |
| 0 ng/mL | 18.2 | - | 18.2 | - |
| 125 ng/mL | 165.5 | - | 165.5 | - |
| 250 ng/mL | 297.4 | - | 297.4 | - |
| 375 ng/mL | 409.0 | - | 409.0 | - |
| 500 ng/mL | 529.9 | + | 529.9 | + |
| 625 ng/mL | 631.3 | + | 631.3 | + |
| 750 ng/mL | 714.0 | + | 714.0 | + |
| 875 ng/mL | 809.1 | + | 809.1 | + |
| 1000 ng/mL | 910.6 | + | 910.6 | + |
Semi-Quantitative Positive/Negative Results:
| 500 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 125 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 250 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 375 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 500 ng/mL | 100.0% | 22 | 22 Positive | 88 | 83 Pos/5 Neg |
| 625 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 750 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 875 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
7
| N=88 | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| (ng/mL) | Mean | SD | % CV | Mean | SD | % CV |
| 0 ng/mL | 330.4 | 2.5 | 0.8% | 330.4 | 3.2 | 1.0% |
| 125 ng/mL | 362.6 | 1.7 | 0.5% | 362.6 | 2.7 | 0.8% |
| 250 ng/mL | 400.5 | 2.6 | 0.6% | 400.5 | 3.5 | 0.9% |
| 375 ng/mL | 429.9 | 2.3 | 0.5% | 429.9 | 3.4 | 0.8% |
| 500 ng/mL | 458.9 | 4.3 | 0.9% | 458.9 | 4.9 | 1.1% |
| 625 ng/mL | 484.6 | 2.3 | 0.5% | 484.6 | 3.6 | 0.7% |
| 750 ng/mL | 498.9 | 3.2 | 0.6% | 498.9 | 4.4 | 0.9% |
| 875 ng/mL | 515.5 | 2.8 | 0.5% | 515.5 | 4.1 | 0.8% |
| 1000 ng/mL | 533.2 | 2.6 | 0.5% | 533.2 | 4.4 | 0.8% |
Precision: Qualitative, mA/min
Qualitative Positive/Negative Results:
| 500 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 125 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 250 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 375 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Negative |
| 500 ng/mL | 100.0% | 22 | 15 Pos/7 Neg | 88 | 48 Pos/40 Neg |
| 625 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 750 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 875 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
8
Performance Characteristics Summary: continued
Hitachi 717 Analyzer
Limit of Detection: d-methamphetamine and d-amphetamine
The lowest concentration that can be differentiated from the negative urine with 95% confidence is determined as 50 ng/mL for both d-methamphetamine and d-amphetamine.
Linearity: d-methamphetamine
Hitachi 717 Instrument: 0 - 2000 ng/mL When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow: y = 0.9717x + 5.7341. r2 = 0.9971
Linearity: d-amphetamine
Hitachi 717 Instrument: 0 - 2000 ng/mL When comparing the result (y) and target (x) value, using the least squares regression technique, the regression equation and correlation are as follow: y = 0.9447x + 24.34, r4=0.9978
Method Comparison - Clinical Samples : d-methamphetamine
From a total of eighty-six (86) clinical unaltered samples: 500 ng/mL Cutoff Semi-Quantitative Data: 100% agreement with positive, 67.4% agreement with negative samples
Qualitative Data: 100% agreement with positive, 69.8% agreement with negative samples
Method Comparison - Clinical Samples : d-amphetamine
From a total of one-hundred and eleven (111) clinical unaltered samples: 500 ng/mL Cutoff
Semi-Quantitative Data: 97.8% agreement with positive, 100% agreement with negative samples
Qualitative Data: 96.4% agreement with positive, 100% agreement with negative samples
Endogenous Compound Interference and Specificity - Cross-Reactivity: d-methamphetamine and d-amphetamine
This assay showed cross-reactivity with four compounds: PMA, MDA, MDMA, and MDEA due to their similar chemical structures. No significant undesired cross reactants or endogenous substance interference was observed for both d-methamphetamine and damphetamine otherwise.
Summary:
The information provided in this pre-market notification demonstrates that the LZI Amphetamines 500 Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by chromatography/mass spectrometry (GC/MS or LC/MS), an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the LZI 500 Amphetamines Enzyme Immunoassay is safe and effective for its stated intended use.
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Lin-Zhi International, Inc. c/o Dr. Bernice Lin VP Operations 670 Almanor Avenue Sunnyvale, CA 94085
DEC 2 8 2010
Re: K102210
Trade Name: LZI Amphetamines 500 Homogeneous Enzyme Immunoassay, Amphetamines 500 Drugs of Abuse Calibrators and Controls Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJC, DJC, DLJ, LAS Dated: December 17 2010 Received: December 17, 2010
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (2) CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerelv vours.
G.C.
Courmey Harper, Ph.D. 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
DEC 28 2010
510(k) Number (if known): K102210
Device Name: Amphetamines 500 Enzyme Immunoassay Amphetamines 500 Calibrators and Controls
Indications for Use:
The LZI Amphetamines 500 Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of amphetamine and methamphetamine in human urine, at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Amphetamines Enzyme Immunoassay.
The LZI Amphetamines 500 Drugs of Abuse (DAU) Controls are for use as assaved quality control materials to monitor the precision of the LZI Amphetamines 500 Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive
Prescription Use J AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
currence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Per 21 CFR 801.109)
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K102270
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