The Amphetamines Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of amphetamines in human urine.

The Amphetamines Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Device Description

L.ZI's Amphetamines Enzyme Immunoassay is a ready-to-use, liguid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect amphetamine and/or methamphetamine in human urine with minimal cross-reactivity to other drugs of abuse, and common prescription drugs.

The assay is based on competition between amphetamines labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme, and free drugs from the urine sample for a fixed amount of specific antibody mixtures. In the absence of free drugs from the urine sample the specific antibodies bind to the drugs labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 mm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Predicate Device K934891)	Reported Device Performance (LZI's Amphetamines EIA)
Within Run Precision:
- Qualitative Negative	Mean Rate: 312, SD: 1	Mean Rate: 273.0, SD: 0.95, % CV: 0.35
- Qualitative 750 ng/mL	Mean Rate: 418, SD: 2	Mean Rate: 390.0, SD: 1.45, % CV: 0.37
- Qualitative 1000 ng/mL	Mean Rate: 443, SD: 2	Mean Rate: 415.7, SD: 1.41, % CV: 0.34
- Qualitative 1250 ng/mL	Mean Rate: 468, SD: 2	Mean Rate: 439.0, SD: 1.63, % CV: 0.37
- Qualitative 2000 ng/mL	Mean Rate: 513, SD: 3	Mean Rate: 480.5, SD: 1.42, % CV: 0.30
- Semi-quantitative	No data available	750 ng/mL: Mean Rec. 751.1, SD 9.83, % CV 1.31
		1000 ng/mL: Mean Rec. 1008.6, SD 14.02, % CV 1.39
		1250 ng/mL: Mean Rec. 1249.6, SD 17.24, % CV 1.38
Run-To-Run Precision:
- Qualitative Negative	No data available	Mean Rate: 272.9, SD: 2.28, % CV: 0.84
- Qualitative 750 ng/mL	No data available	Mean Rate: 390.5, SD: 2.88, % CV: 0.74
- Qualitative 1000 ng/mL	No data available	Mean Rate: 415.9, SD: 3.04, % CV: 0.73
- Qualitative 1250 ng/mL	No data available	Mean Rate: 439.1, SD: 3.60, % CV: 0.82
- Qualitative 2000 ng/mL	No data available	Mean Rate: 479.6, SD: 3.47, % CV: 0.72
- Semi-quantitative	No data available	750 ng/mL: Mean Rec. 756.6, SD 14.81, % CV 1.96
		1000 ng/mL: Mean Rec. 997.7, SD 25.01, % CV 2.51
		1250 ng/mL: Mean Rec. 1265.2, SD 29.54, % CV 2.33
Sensitivity	10 ng/mL	30 ng/mL
Accuracy (Positive)	100% agreement (vs. commercially available EIA)	100% agreement (vs. DRI's Amphetamines EIA)
Accuracy (Negative)	100% agreement (vs. commercially available EIA)	100% agreement (vs. DRI's Amphetamines EIA)
Analytical Recovery:
- Qualitative	No data available	100% accurate on positive vs. negative tests
- Semi-quantitative	No data available	Quantitate within 10% of nominal concentration between 300 ng/mL and 1900 ng/mL. 104.2% recovery at 750 ng/mL, 101.2% recovery at 1250 ng/mL
Specificity	See attached DRI's package insert	Comparable to the predicate device

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

Sample Size: For the Accuracy study (comparison to predicate device), the sample size was n = 218.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It implies the data was collected for this comparative study.

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

There were no experts used to establish ground truth in the traditional sense of medical image interpretation by human experts. The ground truth for the device's performance was established by comparing its results to a legally marketed predicate device (DRI's Amphetamines EIA) and by reference to nominal concentrations for precision and recovery studies.

4. Adjudication Method for the Test Set

Not applicable, as this is a chemical immunoassay, not a system requiring human adjudication of results. The comparison was directly against a predicate device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a homogeneous enzyme immunoassay for chemical analysis, not an AI or imaging system involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone immunoassay. The performance characteristics (precision, accuracy, sensitivity, analytical recovery, specificity) are reported for the algorithm/device itself, without human interpretation as part of the primary test result. The "human-in-the-loop" equivalent would be a lab technician performing the test and reading the spectrophotometric output, not an interpretive process.

7. The Type of Ground Truth Used

The ground truth for the test set was established primarily through:

Comparison to a Predicate Device: DRI's Amphetamines EIA (K934891) served as the reference for accuracy.
Nominal Concentrations: For precision and analytical recovery studies, the "true" values were the known, spiked concentrations of amphetamines.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. This device is a chemical immunoassay based on specific antibody-antigen reactions, not a machine learning model that undergoes training. Therefore, this information is not applicable.

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

Not applicable, as there is no "training set" for this type of medical device.

Summary

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K020395

JUN 0 4 2002

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, Address, and Contact

Lin-Zhi International, Inc. 2391 Zanker Road, Suite 340 San Jose, CA 95131-1124 Phone: (408) 944-0360 Fax: (408) 944-0359

Chiu Chin Chang, Ph.D. Contact: VP. R&D

Device Name and Classification

Classification Name:	Amphetamine test system, Class II, DKZ (91),21 CFR 862.3100
Common Name:	Homogeneous enzyme immunoassay for the determinationof amphetamines levels in urine.
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.'s Amphetamines Enzyme Immunoassay is substantially equivalent to the Amphetamines Enzyme Immunoassay by Diagnostic Reagents Inc. (now Microgenics, Inc.), cleared under premarket notification K934891.

LZI's Amphetamines Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.

Device Description

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Intended Use

The Amphetamines Enzyme Immunoassav is a homogeneous enzyme innnunoassay with a 1000 ng/mL cutoff. The assav is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine.

Comparison to Predicate Device

LZI's Amphetamines Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed DRI's Amphetamines Enzyme Immunoassay (K934891).

The following table compares LZI's Amphetamines Enzyme Immunoassay with the predicate device, DRI's Amphetamines Enzyme Immunoassay:

Similarities:

. Both assays are for qualitative and semi-quantitative determination of amphetamines in human urine.
. Both assays use the same method principle, and device components.
Both assay use 1000 ng/mL as cutoff level per recommendations of The . Substance Abuse and Metal Health Services Administration (SAMHSA).

Differences:

LZI's Amphetamines Enzyme Immunoassay uses 5 calibrators for the semiquantitative analysis of amphetamines in urine. DRI's Amphetamines ElA uses 3 calibrators for semi-quantitative purpose previously. Additional calibrators (to a total of 5 calibrators) are also available now.

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(Comparison to Predicate Device, continued)

Performance Characteristics

Feature	DRI's Amphetamines EIA			LZI's Amphetamines EIA
Within Run Precision:
Qualitative:		Mean Rate	SD	% CV		Mean Rate	SD	% CV
	Negative	312	1	-	Negative	273.0	0.95	0.35
	750 ng/mL	418	2	-	750 ng/mL	390.0	1.45	0.37
	1000 ng/mL	443	2	-	1000 ng/mL	415.7	1.41	0.34
	1250 ng/mL	468	2	-	1250 ng/mL	439.0	1.63	0.37
	2000 ng/mL	513	3	-	2000 ng/mL	480.5	1.42	0.30
Semi-quantitative:	No data available					Mean Recovery	SD	% CV
					750 ng/mL	751.1	9.83	1.31
					1000 ng/mL	1008.6	14.02	1.39
					1250 ng/mL	1249.6	17.24	1.38
Run-To-Run Precision:
	Qualitative:	No data available				Mean Rate	SD	% CV
					Negative	272.9	2.28	0.84
					750 ng/mL	390.5	2.88	0.74
					1000 ng/mL	415.9	3.04	0.73
					1250 ng/mL	439.1	3.60	0.82
					2000 ng/mL	479.6	3.47	0.72
Semi-quantitative:	No data available					Mean Recovery	SD	% CV
					750 ng/mL	756.6	14.81	1.96
					1000 ng/mL	997.7	25.01	2.51
					1250 ng/mL	1265.2	29.54	2.33
Sensitivity:	10 ng/mL				30 ng/mL
Accuracy:	Vs. a commercially available EIA			(1) Vs. DRI's Amphetamines EIA (n = 218)
Positive Samples:	100 % agreement			100 % agreement
Negative Samples:	100 % agreement			100 % agreement
Analytical Recovery:
	Qualitative: No data available			100 % accurate on positive vs. negative tests
	Semi-quantitative: No data available			Quantitate within 10% of the nominalconcentration between 300 ng/mL and 1900ng/mL
					104.2 % recovery at 750 ng/mL level (Cutoff -25%)101.2 % recovery at 1250 ng/mL level (Cutoff +25%)

Specificity:	See attached DRI's Amphetamines EIApackage insert			Comparable to the predicate device.

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Conclusion

LZI's Amphetamines Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.

We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Amphetamines Enzyme Immunoassay to other amphetamine test systems currently marketed in the United States.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines underneath them, resembling water or fabric.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 0 4 2002

Chiu Chin Chang, Ph.D. VP. R&D Lin-Zhi International. Inc. 2391 Zanker Road, Suite 340 San Jose. CA 95131-1124

Re: K020395

Trade/Device Name: Amphetamines Enzyme Immunoassay Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: April 24, 2002 Received: April 26, 2002

Dear Dr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 --

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification

Indications for Use Statement

510(k) Number (if known): Kozo395

Device Name: Amphetamines Enzyme Immunoassav

Indications for Use:

The Amphetamines Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.

teun Cooger

(Division Sign-Off)
Division of Clinical Laboratory L
510(k) Number K020395

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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).