LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
Device Facts
| Record ID | K102210 |
|---|---|
| Device Name | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS |
| Applicant | Lin-Zhi International, Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Dec 28, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
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.
Device Story
Homogeneous enzyme immunoassay (ELISA) for detection of amphetamine and methamphetamine in human urine; utilizes automated clinical chemistry analyzers (e.g., Hitachi 717). Principle: competitive binding between sample drug and drug-labeled G6PDH enzyme for fixed antibody; enzyme activity inhibited by antibody binding; free drug in sample displaces labeled enzyme, increasing activity. Active enzyme converts NAD to NADH, measured spectrophotometrically at 340 nm. Used in clinical settings by professionals; provides preliminary results requiring GC/MS or LC/MS confirmation. Assists clinicians in identifying potential drug use; supports professional judgment in clinical decision-making.
Clinical Evidence
No clinical studies performed. Analytical performance established via bench testing. Precision evaluated per CLSI EP5-A2 (n=88 per concentration). Linearity confirmed via serial dilution (r^2 > 0.99). Method comparison against GC/MS or LC/MS conducted on 111 samples for amphetamine and 86 samples for methamphetamine. Interference testing performed for endogenous compounds, specific gravity, pH, and structurally related/unrelated drugs.
Technological Characteristics
Homogeneous enzyme immunoassay. Reagents: mouse monoclonal anti-amphetamines antibodies, G6PDH-labeled drug conjugate, NAD, G6P, stabilizers, 0.09% sodium azide. Detection: spectrophotometric absorbance at 340 nm. Form factor: liquid reagent kit for automated clinical chemistry analyzers. Storage: 2-8 °C.
Indications for Use
Indicated for the qualitative and semi-quantitative determination of amphetamine and methamphetamine in human urine at a 500 ng/mL cutoff. For professional use in clinical settings using automated chemistry analyzers. Not for self-use.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Lin-Zhi International, Inc. Amphetamines Enzyme Immunoassay, Calibrators and Controls for Hitachi 717 Systems (k020395)
Related Devices
- K020395 — AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) · Lin-Zhi International, Inc. · Jun 4, 2002
- K113661 — LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS · Lin-Zhi International, Inc. · Jan 23, 2012
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k102210
B. Purpose for Submission:
New device
C. Measurand:
Amphetamine, Methamphetamine
D. Type of Test:
Qualitative and Semi-Quantitative Enzyme linked Immunoassay (ELISA)
E. Applicant:
Lin-Zhi International, Inc.
F. Proprietary and Established Names:
LZI Amphetamines 500 Homogeneous Enzyme Immunoassay
LZI Amphetamines 500 Drugs of Abuse Calibrators
LZI Amphetamines 500 Drugs of Abuse Controls
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ, enzyme immunoassay, amphetamine | Class II | 21 CFR § 862.3100, Amphetamine test system | Toxicology (91) |
| DJC, thin layer chromatography, methamphetamine | Class II | 21 CFR § 862.3610, Methamphetamine test system | Toxicology (91) |
| DLJ, calibrators, drug specific | Class II | 21 CFR § 862.3200, Clinical toxicology calibrator. | Toxicology (91) |
| LAS, drug specific control materials | Class I | 21 CFR § 862.3280, Clinical toxicology control material. | Toxicology (91) |
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) 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.
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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. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
Performance data was provided for Hitachi 717 analyzer. The assay can be used on a clinical chemistry analyzer capable of measuring absorbance at 340 nanometers.
I. Device Description:
The LZI Amphetamines 500 Homogeneous Enzyme Immunoassay consists of two separately packaged reagents (R1 and R2):
| Reagent | Description |
| --- | --- |
| R1 | Contains two mouse monoclonal anti-amphetamines antibodies, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers and sodium azide as a preservative. |
| R2 | Contains amphetamines-labeled glucose-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide as a preservative. |
Each LZI Amphetamines 500 Drugs of Abuse Calibrator kit contains five calibrators comprised of a human urine matrix containing buffers, stabilizers and less than 0.1% of sodium azide. The controls are prepared by spiking known concentrations of d-methamphetamine into the drug-free matrix. The calibrators cover the calibration range of the assay (0 to 2,000 ng/mL) and are at the following concentrations:
| Calibrator | Target Concentration (ng/mL) |
| --- | --- |
| Negative Calibrator | 0 |
| 250 ng/mL Calibrator | 250 |
| 500 ng/mL Calibrator | 500 |
| 1000 ng/mL Calibrator | 1,000 |
| 2000 ng/mL Calibrator | 2,000 |
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Each LZI Amphetamines 500 Drugs of Abuse Control Kit contains two levels comprised of a human urine matrix containing buffers, stabilizers and less than 0.1% of sodium azide. The controls are prepared by spiking known concentrations of d-methamphetamine into the drug-free matrix. The controls are available at the following concentrations:
| Control | Target Concentration (ng/mL) |
| --- | --- |
| 375 ng/mL Control | 375 |
| 625 ng/mL Control | 625 |
J. Substantial Equivalence Information:
| Predicate device name | Predicate 510(k) number |
| --- | --- |
| LZI Amphetamines Enzyme Immunoassay | k020395 |
Comparison with predicate:
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicate (k020395) |
| 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 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.
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. |
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| Analyte | d-amphetamine and d-methamphetamine | Amphetamines |
| --- | --- | --- |
| Assay Type | Same | Qualitative and Semi-Quantitative |
| Cutoff value | 500 ng/mL | 1000 ng/ml |
| Sample | Same | Urine |
| Methodology | Same | Enzyme linked Immunoassay (ELISA) |
| Test Principle | Same | The assay is an Enzyme linked Immunoassay (ELISA) based on competition between drug (amphetamine and methamphetamine) 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, buprenorphine-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 amphetamine-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. |
| Analyzer | Same | Clinical chemistry analyzer capable of measuring absorbance at 340 nanometers. |
| Detection Wavelength | Same | 340 nanometers |
| Calibrators | Five Levels (0, 250, 500, 1000 and 2000 ng/mL) | Five Levels (0, 500, 1000, 1500, 2000 ng/mL) |
| Controls | Two Levels (375 and 625 ng/mL) | Two Levels (750 and 1250 ng/mL) |
K. Standard/Guidance Document Referenced (if applicable):
EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices
L. Test Principle:
The assay is an Enzyme linked Immunoassay (ELISA) based on competition between drug (amphetamine and methamphetamine) in the sample and drug labeled with the
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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, buprenorphine-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 amphetamine-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.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
The sponsor conducted two separate precision studies on the Hitachi 717 analyzer using samples containing d-methamphetamine or d-amphetamine. The precision studies were performed according to CLSI EP5-A2. Samples were prepared by spiking a negative human urine pool with either d-methamphetamine or d-amphetamine at the following concentrations: zero drug (-100%), -75%, -50%, and -25% below the cutoff, cutoff, and +25%, +50%, +75%, and +100% above the cutoff. Samples were tested in 2 replicates per run, 2 runs per day for 22 days, total n=88. Results of the studies are presented below:
Semi-Quantitative Precision Data for d-amphetamine
| 500 ng/mL Cutoff Result | | Within Run | | Total Precision | |
| --- | --- | --- | --- | --- | --- |
| Sample Concentration (ng/mL) | % of Cutoff | Number of Determinations | Immunoassay Result | Number of Determinations | Immunoassay Result |
| 0 | -100% | 22 | 22 Negative | 88 | 88 Negative |
| 125 | -75% | 22 | 22 Negative | 88 | 88 Negative |
| 250 | -50% | 22 | 22 Negative | 88 | 88 Negative |
| 375 | -25% | 22 | 22 Negative | 88 | 88 Negative |
| 500 | 0 | 22 | 22 Positive | 88 | 83 Positive
5 Negative |
| 625 | +25% | 22 | 22 Positive | 88 | 88 Positive |
| 750 | +50% | 22 | 22 Positive | 88 | 88 Positive |
| 875 | +75% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 | +100% | 22 | 22 Positive | 88 | 88 Positive |
Qualitative Precision Data for d-amphetamine
| 500 ng/mL Cutoff Result | | Within Run | | Total Precision | |
| --- | --- | --- | --- | --- | --- |
| Sample Concentration (ng/mL) | % of Cutoff | Number of Determinations | Immunoassay Result | Number of Determinations | Immunoassay Result |
| 0 | -100% | 22 | 22 Negative | 88 | 88 Negative |
| 125 | -75% | 22 | 22 Negative | 88 | 88 Negative |
| 250 | -50% | 22 | 22 Negative | 88 | 88 Negative |
| 375 | -25% | 22 | 22 Negative | 88 | 88 Negative |
| 500 | 0 | 22 | 15 Positive | 88 | 48 Positive |
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| | | | 7 Negative | | 40 Negative |
| --- | --- | --- | --- | --- | --- |
| 625 | +25% | 22 | 22 Positive | 88 | 88 Positive |
| 750 | +50% | 22 | 22 Positive | 88 | 88 Positive |
| 875 | +75% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 | +100% | 22 | 22 Positive | 88 | 88 Positive |
Semi-Quantitative Precision Data for d-methamphetamine
| 500 ng/mL Cutoff Result | | Within Run | | Total Precision | |
| --- | --- | --- | --- | --- | --- |
| Sample Concentration (ng/mL) | % of Cutoff | Number of Determinations | Immunoassay Result | Number of Determinations | Immunoassay Result |
| 0 | -100% | 22 | 22 Negative | 88 | 88 Negative |
| 125 | -75% | 22 | 22 Negative | 88 | 88 Negative |
| 250 | -50% | 22 | 22 Negative | 88 | 88 Negative |
| 375 | -25% | 22 | 22 Negative | 88 | 88 Negative |
| 500 | 0 | 22 | 3 Positive
19 Negative | 88 | 18 Positive
70 Negative |
| 625 | +25% | 22 | 22 Positive | 88 | 88 Positive |
| 750 | +50% | 22 | 22 Positive | 88 | 88 Positive |
| 875 | +75% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 | +100% | 22 | 22 Positive | 88 | 88 Positive |
Qualitative Precision Data for d-methamphetamine
| 500 ng/mL Cutoff Result | | Within Run | | Total Precision | |
| --- | --- | --- | --- | --- | --- |
| Sample Concentration (ng/mL) | % of Cutoff | Number of Determinations | Immunoassay Result | Number of Determinations | Immunoassay Result |
| 0 | -100% | 22 | 22 Negative | 88 | 88 Negative |
| 125 | -75% | 22 | 22 Negative | 88 | 88 Negative |
| 250 | -50% | 22 | 22 Negative | 88 | 88 Negative |
| 375 | -25% | 22 | 22 Negative | 88 | 88 Negative |
| 500 | 0 | 22 | 13 Positive
9 Negative | 88 | 54 Positive
34 Negative |
| 625 | +25% | 22 | 22 Positive | 88 | 88 Positive |
| 750 | +50% | 22 | 22 Positive | 88 | 88 Positive |
| 875 | +75% | 22 | 22 Positive | 88 | 88 Positive |
| 1000 | +100% | 22 | 22 Positive | 88 | 88 Positive |
b. Linearity/assay reportable range:
Linearity across the range was confirmed in two separate studies by serially diluting a spiked urine pool containing d-methamphetamine or d-amphetamine in desired levels listed in the table below. Each sample was assayed in 10 replicates on Hitachi 717 analyzer in the semi-quantitative mode. The results were averaged and compared to the expected result and the percent recovery was calculated. Results are presented below:
| Linearity Data for d-amphetamine | | | Linearity Data for d-methamphetamine | | |
| --- | --- | --- | --- | --- | --- |
| Expected | Observed | % Recovery | Expected | Observed | % Recovery |
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Linear regression analysis of the results yielded the following:
Amphetamine: $y = 0.9447x + 24.34, r^2 = 0.9978$ .
Methamphetamine: $y = 0.9717x + 5.734, r^2 = 0.9971$ .
c. Traceability, Stability, Expected values (controls, calibrators, or methods): A stock solution of $1000\mu \mathrm{g / mL}$ d-methamphetamine purchased from a commercial source is spiked into the calibrator and controls to the desired concentration. The concentration of the calibrator and controls are confirmed by GC/MS. The sponsor claimed an open vial stability of 18 months at 2 to $8^{\circ}\mathrm{C}$ for the calibrator and control bottles. After the calibrator and control bottles are initially opened, the screw-on caps can be resealed.
d. Detection limit:
Performance at low drug concentrations in the semi-quantitative assay was characterized by determination of recovery (see section M1b above).
e. Analytical specificity:
The sponsor prepared urine-free samples spiked with d-amphetamine or d-methamphetamine at control levels ( $\pm 25\%$ of the $500~\mathrm{ng / mL}$ cutoff concentration) and evaluated the possible interference from endogenous compounds on the Hitachi 717 analyzer. No positive or negative interference due to endogenous compounds tested was observed. The results are listed below.
Endogenous Compounds Interference Data for d-amphetamine
| Compound | Concentration (mg/dL) | -25% d-amphetamine (375 ng/mL) | +25% d-amphetamine (625 ng/mL) |
| --- | --- | --- | --- |
| Acetone | 1000 | Negative | Positive |
| Ascorbic Acid | 1500 | Negative | Positive |
| Creatinine | 500 | Negative | Positive |
| Ethanol | 1000 | Negative | Positive |
| Galactose | 10 | Negative | Positive |
| γ-Globulin | 500 | Negative | Positive |
| Glucose | 1500 | Negative | Positive |
| Hemoglobin | 300 | Negative | Positive |
| Protein | 1000 | Negative | Positive |
| Glucose | 1000 | Negative | Negative |
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| Compound | Concentration (mg/dL) | -25% d-amphetamine (375 ng/mL) | +25% d-amphetamine (625 ng/mL) |
| --- | --- | --- | --- |
| Human Serum Albumin | 500 | Negative | Positive |
| Oxalic Acid | 100 | Negative | Positive |
| Riboflavin | 2.5 | Negative | Positive |
| Sodium Chloride | 6000 | Negative | Positive |
| Urea | 2000 | Negative | Positive |
Endogenous Compounds Interference Data for d-methamphetamine
| Compound | Concentration (mg/dL) | -25% d-methamphetamine (375 ng/mL) | +25% d-methamphetamine (625 ng/mL) |
| --- | --- | --- | --- |
| Acetone | 1000 | Negative | Positive |
| Ascorbic Acid | 1500 | Negative | Positive |
| Creatinine | 500 | Negative | Positive |
| Ethanol | 1000 | Negative | Positive |
| Galactose | 10 | Negative | Positive |
| γ-Globulin | 500 | Negative | Positive |
| Glucose | 1500 | Negative | Positive |
| Hemoglobin | 300 | Negative | Positive |
| Human Serum Albumin | 500 | Negative | Positive |
| Oxalic Acid | 100 | Negative | Positive |
| Riboflavin | 2.5 | Negative | Positive |
| Sodium Chloride | 6000 | Negative | Positive |
| Urea | 2000 | Negative | Positive |
To test for possible positive and/or negative interference from specific gravity, the sponsor prepared samples containing d-amphetamine or d-methamphetamine at control levels (±25% of the 500 ng/mL cutoff concentration) with specific gravities ranging from 1.002 to 1.030. No positive or negative interference due to specific gravity was observed.
To test for potential positive or negative interference from pH the sponsor prepared samples containing d-amphetamine or d-methamphetamine at control levels (±25% of the 500 ng/mL cutoff concentration) with pH values of 3, 4.5, 5, 6, 7, 8 and 11. No negative interference due to pH was observed.
Cross reactivity of various potential interfering drugs were tested by spiking a final concentration of up to 500,000 ng/mL of each substance into drug free urine, and then evaluated with the assay's calibrated dose-response curve. The following table summarizes the approximate quantity of each compound that is equivalent in assay reactivity to the 500 ng/mL d-Methamphetamine cutoff. The sponsor claimed cross-reactivity with four compounds: PMA, MDA, MDMA, and Fenfluramine. The results are presented below.
Structurally Related Compounds Interference Data
| Compound | Concentration (ng/dL) | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- | --- |
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Structurally Unrelated Compounds Interference Data
| Compound | Concentration (ng/dL) | Response equivalent to cutoff (ng/mL) | % Cross-reactivity |
| --- | --- | --- | --- |
| Acetaminophen | 500,000 | 108.6 | 0.02 % |
| Acetylsalicylic acid | 500,000 | 97.8 | 0.02 % |
| Amobarbital | 500,000 | 100.1 | 0.02 % |
| Benzoylecgonine | 500,000 | 103.1 | 0.02 % |
| Bromopheniramine | 500,000 | 125.0 | 0.02 % |
| Bupropion | 500,000 | 194.0 | 0.04 % |
| Buspiron | 500,000 | 170.0 | 0.03 % |
| Caffeine | 500,000 | 105.1 | 0.02 % |
| Chlorpheniramine | 500,000 | 129.7 | 0.03 % |
| Chlorpromazine | 500,000 | 159.7 | 0.03 % |
| Codeine | 500,000 | 109.4 | 0.02 % |
| Dextromethorphan | 500,000 | 107.2 | 0.02 % |
| Doxepine | 500,000 | 240.4 | 0.05 % |
| Meperidine | 500,000 | 30.8 | 0.01 % |
| Methadone | 500,000 | 121.2 | 0.02 % |
| Methapyrilene | 500,000 | 191.5 | 0.04 % |
| Methaqualone | 500,000 | 101.6 | 0.02 % |
| Morphine | 500,000 | 62.9 | 0.01 % |
| Oxazepam | 500,000 | 101.2 | 0.02 % |
| Phencyclidine | 500,000 | 29.3 | 0.01 % |
| Phenobarbital | 500,000 | 99.7 | 0.02 % |
| Phenothiazine | 500,000 | 65.0 | 0.01 % |
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f. Assay cut-off:
There is a 500 ng/mL cutoff concentration claimed for both d-amphetamine and methamphetamine.
2. Comparison studies:
a. Method comparison with predicate device:
The sponsor conducted two separate method comparison studies to evaluate the performance of the device for detection of d-methamphetamine or d-amphetamine. For method comparison study for the detection of amphetamine, one hundred and eleven unaltered samples (55 negative and 56 positive samples) were tested with LZI Amphetamines 500 Enzyme Immunoassay on the Hitachi 717 analyzer and compared against the results (d-amphetamine and d-methamphetamine concentration) obtained with GC/MS or LC/MS. The results of the studies are presented below:
| Semi-Quantitative Method Comparison Data for Amphetamine 500 ng/mL Cutoff | | | | | |
| --- | --- | --- | --- | --- | --- |
| Candidate Device Results | Negative | <50 % of the cutoff concentration (1-250 ng/mL) | Near Negative Cutoff (250-500 ng/mL) | Near Positive Cutoff (500-750 ng/mL) | High Positive (>750 ng/mL) |
| Positive (56 samples) | 0 | 0 | 0 | 10 | 45 |
| Negative (55 samples) | 12 | 22 | 21 | 1 | 0 |
Summary of Discordant Results (Semi-Quantitative)
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| Qualitative Method Comparison Data for Amphetamine 500 ng/mL Cutoff | | | | |
| --- | --- | --- | --- | --- |
| Candidate Device Results | Negative | <50 % of the cutoff concentration (1-250 ng/mL) | Near Negative Cutoff (250-500 ng/mL) | Near Positive Cutoff (500-750 ng/mL) High Positive (>750 ng/mL) |
| Positive (56 samples) | 0 | 0 | 0 | 9 |
| Negative (55 samples) | 12 | 22 | 21 | 2 |
Summary of Discordant Results (Qualitative)
| Assay | Cutoff Value (ng/mL) | Candidate Device Result | GC/MS or LC/MS result |
| --- | --- | --- | --- |
| Amphetamine | 500 | Negative | 510 ng/mL amphetamine 0 ng/mL methamphetamine |
| Amphetamine | 500 | Negative | 531 ng/mL amphetamine 0 ng/mL methamphetamine |
For method comparison study for the detection of methamphetamine, eighty-six unaltered samples (43 negative and 43 positive samples) were tested with LZI Amphetamines 500 Enzyme Immunoassay on the Hitachi 717 analyzer and compared against the results (d-amphetamine and d-methamphetamine concentration) obtained with GC/MS or LC/MS. The results of the studies are presented below:
| Semi-Quantitative Method Comparison Data for Methamphetamine 500 ng/mL Cutoff | | | | | |
| --- | --- | --- | --- | --- | --- |
| Candidate Device Results | Negative | <50 % of the cutoff concentration (1-250 ng/mL) | Near Negative Cutoff (250-500 ng/mL) | Near Positive Cutoff (500-750 ng/mL) | High Positive (>750 ng/mL) |
| Positive (43 samples) | 0 | 4 | 10 | 9 | 34 |
| Negative (43 samples) | 4 | 20 | 5 | 0 | 0 |
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Summary of Discordant Results (Semi-Quantitative)
| Assay | Cutoff Value (ng/mL) | Candidate Device Result | GC/MS or LC/MS result |
| --- | --- | --- | --- |
| Methamphetamine | 500 | Positive | 16 ng/mL methamphetamine 584 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 114 ng/mL methamphetamine 621 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 133 ng/mL methamphetamine 1029 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 184 ng/mL methamphetamine 957 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 269 ng/mL methamphetamine 397 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 306 ng/mL methamphetamine 244 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 385 ng/mL methamphetamine 235 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 388 ng/mL methamphetamine 178 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 402 ng/mL methamphetamine 226 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 409 ng/mL methamphetamine 147 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 413 ng/mL methamphetamine 708 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 413 ng/mL methamphetamine 130 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 458 ng/mL methamphetamine 180 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 471 ng/mL methamphetamine 108 ng/mL amphetamine |
| Qualitative Method Comparison Data for Methamphetamine 500 ng/mL Cutoff | | | | | |
| --- | --- | --- | --- | --- | --- |
| Candidate Device Results | Negative | <50 % of the cutoff concentration (1-250 ng/mL) | Near Negative Cutoff (250-500 ng/mL) | Near Positive Cutoff (500-750 ng/mL) | High Positive (>750 ng/mL) |
| Positive (43 samples) | 0 | 4 | 9 | 9 | 34 |
| Negative (43 samples) | 4 | 20 | 6 | 0 | 0 |
Summary of Discordant Results (Qualitative)
| Assay | Cutoff Value (ng/mL) | Candidate Device Result | GC/MS or LC/MS result |
| --- | --- | --- | --- |
| Methamphetamine | 500 | Positive | 16 ng/mL methamphetamine 584 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 114 ng/mL methamphetamine 621 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 133 ng/mL methamphetamine 1029 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 184 ng/mL methamphetamine 957 ng/mL amphetamine |
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| Assay | Cutoff Value (ng/mL) | Candidate Device Result | GC/MS or LC/MS result |
| --- | --- | --- | --- |
| Methamphetamine | 500 | Positive | 269 ng/mL methamphetamine 397 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 306 ng/mL methamphetamine 244 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 385 ng/mL methamphetamine 235 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 388 ng/mL methamphetamine 178 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 409 ng/mL methamphetamine 147 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 413 ng/mL methamphetamine 708 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 413 ng/mL methamphetamine 130 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 458 ng/mL methamphetamine 180 ng/mL amphetamine |
| Methamphetamine | 500 | Positive | 471 ng/mL methamphetamine 108 ng/mL amphetamine |
b. Matrix comparison: Not applicable
3. Clinical studies:
a. Clinical Sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable
4. Clinical cut-off: Not applicable
5. Expected values/Reference range: Not applicable
N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
