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 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.

AI/ML Overview

Acceptance Criteria and Device Performance for LZI Amphetamines 500 Enzyme Immunoassay

This document outlines the acceptance criteria and reported device performance for the LZI Amphetamines 500 Enzyme Immunoassay, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance characteristics, primarily precision and method comparison (agreement with GC/MS). The acceptance criteria are not explicitly stated as "acceptance criteria" but are implied by the reported performance, with the device demonstrating high agreement rates with confirmatory methods for positive and negative samples, and good precision metrics.

Implicit Acceptance Criteria (based on reported performance for a device seeking substantial equivalence):

High agreement (e.g., 96-100%) with a confirmatory method (GC/MS) for both positive and negative clinical samples.
Reliable qualitative determination (positive/negative) around the 500 ng/mL cutoff, with minimal misclassification at concentrations significantly above or below the cutoff.
Acceptable precision (low coefficient of variation (CV%) and standard deviation (SD)) for semi-quantitative measurements across various concentrations, indicating consistent results within and between runs.

Table 1: Device Performance Summary for LZI Amphetamines 500 Enzyme Immunoassay

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (d-methamphetamine)	Reported Device Performance (d-amphetamine)
Method Comparison (Clinical Samples) - 500 ng/mL Cutoff
Agreement with Positive Samples (Semi-Quantitative)	High agreement (e.g., ≥95% agreement) with confirmatory method (GC/MS)	100% agreement	97.8% agreement
Agreement with Negative Samples (Semi-Quantitative)	High agreement (e.g., ≥95% agreement) with confirmatory method (GC/MS)	67.4% agreement (This value is lower than ideal but likely considered acceptable in the context of screening tests where confirmation is required. It suggests some samples below the cutoff might be reported as positive by EIA, indicating a need for GC/MS confirmation as stated in the intended use.)	100% agreement
Agreement with Positive Samples (Qualitative)	High agreement (e.g., ≥95% agreement) with confirmatory method (GC/MS)	100% agreement	96.4% agreement
Agreement with Negative Samples (Qualitative)	High agreement (e.g., ≥95% agreement) with confirmatory method (GC/MS)	69.8% agreement (Similar considerations as above for semi-quantitative negative samples.)	100% agreement
Precision (Qualitative Results at 500 ng/mL Cutoff)
Samples at +25% to +100% of Cutoff (>625 ng/mL)	Consistent positive results (e.g., 100% positive)	100% Positive (Across all tested concentrations for Total Precision)	100% Positive (Across all tested concentrations for Total Precision)
Samples at -100% to -25% of Cutoff (<375 ng/mL)	Consistent negative results (e.g., 100% negative)	100% Negative (Across all tested concentrations for Total Precision)	100% Negative (Across all tested concentrations for Total Precision)
Samples at Cutoff (500 ng/mL)	Expected mix of positive/negative, but with a reasonable proportion of positive given inherent variability around the cutoff	d-methamphetamine: Total Precision: 54 Pos/34 Neg (61.4% Positive) d-amphetamine: Total Precision: 48 Pos/40 Neg (54.5% Positive) These values reflect the expected variation around the cutoff and demonstrate that the device is sensitive enough to detect the drug at the cutoff level.	d-methamphetamine: Total Precision: 83 Pos/5 Neg (94.3% Positive) d-amphetamine: Total Precision: 48 Pos/40 Neg (54.5% Positive) These values reflect the expected variation around the cutoff and demonstrate that the device is sensitive enough to detect the drug at the cutoff level.
Limit of Detection	Detectable at low concentrations with specified confidence (e.g., 95%)	50 ng/mL (for both d-methamphetamine and d-amphetamine)	50 ng/mL (for both d-methamphetamine and d-amphetamine)
Linearity (r^2)	High correlation (e.g., r^2 ≥ 0.99)	d-methamphetamine: r^2 = 0.9971	d-amphetamine: r^2 = 0.9978
Cross-Reactivity	Minimal significant undesired cross-reactants	Cross-reactivity observed for PMA, MDA, MDMA, and MDEA (due to similar chemical structures), but no other significant undesired cross-reactants or endogenous substance interference.	Cross-reactivity observed for PMA, MDA, MDMA, and MDEA (due to similar chemical structures), but no other significant undesired cross-reactants or endogenous substance interference.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Precision Studies: 88 determinations for each concentration level (22 determinations per run across 4 runs). This applies to both d-methamphetamine and d-amphetamine.
- Method Comparison - Clinical Samples:
  - d-methamphetamine: 86 clinical unaltered samples.
  - d-amphetamine: 111 clinical unaltered samples.
Data Provenance: The document does not explicitly state the country of origin. The samples for method comparison are referred to as "clinical unaltered samples," implying they were collected from human subjects in a clinical setting. It is retrospective as these are pre-existing clinical samples used for evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth. Instead, the ground truth for the clinical samples was established using "Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS)," which is cited as the "preferred confirmatory method." This is a laboratory-based, objective chemical analysis, rather than expert interpretation.

4. Adjudication Method for the Test Set

Since the ground truth for the method comparison studies was established by a laboratory-based confirmatory method (GC/MS or LC/MS) and not by expert interpretation, there was no adjudication method (e.g., 2+1, 3+1, none) in the traditional sense. The results of the immunoassay were compared directly against the quantitative analytical results of the confirmatory method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done in this 510(k) summary. This type of study typically applies to imaging or diagnostic devices where human interpretation is a key component, which is not the primary focus of this immunoassay device approval. The study focuses on the device's analytical performance.

6. Standalone Performance Study

Yes, a standalone study was done. The entire performance characterization presented (precision, limit of detection, linearity, method comparison, and cross-reactivity) describes the algorithm/device-only performance without human intervention in the assay execution or primary result interpretation. The device's output (quantitative or qualitative result) is directly compared to the ground truth.

7. Type of Ground Truth Used

The type of ground truth used for the clinical samples in the method comparison study was laboratory-based confirmatory analysis, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). For precision studies, the "ground truth" was established by preparing known concentrations of d-methamphetamine and d-amphetamine in urine. For cross-reactivity, known interfering substances were added.

8. Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This type of product (a homogeneous enzyme immunoassay) is typically developed and optimized during a multi-stage R&D process, but the performance studies described in a 510(k) summary generally focus on the validation of the final, locked-down device using a distinct test set. The calibrators and controls used for the assay itself are part of the device's operational design, not a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is explicitly mentioned in the context of a machine learning-like development process, information on how its ground truth was established is not available in this document. The document describes the assay's principle (competition between drug and drug-labeled enzyme for antibody binding) as a chemical reaction rather than an algorithm that requires a training set. Ground truth for internal development and optimization would have involved similar analytical methods (e.g., gravimetric preparation, GC/MS) for defining known concentrations and evaluating initial formulations.

Summary

{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, AmphetaminesClass II, DKZ (91 Toxicology),21 CFR 862.3100
	Thin Layer Chromatography, MethamphetamineClass 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 Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.

{2}------------------------------------------------

Intended Use

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.

{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.

DeviceCharacteristics	Subject Device (K102210)LZI Amphetamines 500 EnzymeImmunoassay	Predicate Device (K020395)LZI Amphetamines EnzymeImmunoassay
Intended Use	The LZI Amphetamines 500 EnzymeImmunoassay, when used in conjunctionwith Hitachi 717 automated clinicalsystem analyzers, is intended for thequalitative and semi-quantitativedetermination of amphetamine andmethamphetamine in human urine, at acutoff value of 500 ng/mL. The assay isdesigned for professional use with anumber of automated clinical chemistryanalyzers.This assay provides a rapid screening procedurefor determining the presence of Amphetamines inurine. The assay provides only a preliminaryanalytical result. A more specific alternativechemical method must be used in order to obtain aconfirmed analytical result. Gas or liquidchromatography/mass spectrometry (GC/MS orLC/MS) is the preferred confirmatory method.Clinical consideration and professional judgmentshould be exercised with any drug of abuse testresult, particularly when the preliminary test resultis positive.	The LZI Amphetamines EnzymeImmunoassay, when used in conjunctionwith Hitachi 717 automated clinicalsystem analyzers, is intended for thequalitative and semi-quantitativedetermination of Amphetamines in humanurine, at a cutoff value of 1000 ng/mL.The assay is designed for professional usewith a number of automated clinicalchemistry analyzers.This assay provides a rapid screening procedurefor determining the presence of Amphetamines inurine. The assay provides only a preliminaryanalytical result. A more specific alternativechemical method must be used in order to obtain aconfirmed analytical result. Gas or liquidchromatography/mass spectrometry (GC/MS orLC/MS) is the preferred confirmatory method.Clinical consideration and professional judgmentshould be exercised with any drug of abuse testresult, particularly when the preliminary test resultis positive.
Analyte	d-methamphetamine and d-amphetamine	Amphetamines
Cutoff	500 ng/ml	1000 ng/mL
Matrix	Urine	Urine
CalibratorsLevel	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 CutoffConcentration		Number ofDetermination	ImmunoassayResult	Number ofDetermination	ImmunoassayResult
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
SampleConcentration	% of Cutoff	Number ofDetermination	ImmunoassayResult	Number ofDetermination	ImmunoassayResult
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
SampleConcentration	% of Cutoff	Number ofDetermination	ImmunoassayResult	Number ofDetermination	ImmunoassayResult
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
SampleConcentration	% of Cutoff	Number ofDetermination	ImmunoassayResult	Number ofDetermination	ImmunoassayResult
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

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.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.

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).

{10}------------------------------------------------

Page 2 -

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

{11}------------------------------------------------

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 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.

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

Page 2 of 20

Regulation Number and Section

§ 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).