The Opiate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of opiates in human urine.

The Opiate 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

LZI's Opiate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect opiates in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Lin-Zhi International, Inc.' Opiate Enzyme Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the stated "acceptable results." Since this is a 510(k) submission for an in-vitro diagnostic, the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate. The reported performance of the new device is directly compared to the predicate's performance or presented as standalone performance that is considered acceptable.

Performance Characteristic	Predicate Device Performance (DRI® Opiate EIA)	LZI's Opiate EIA Performance (New Device)	Acceptance Criteria (Implied)
Within Run Precision (Qualitative)			Comparable to predicate device; low %CVs.
Negative	- (Not reported directly, but implied low)	Mean Rate: 291.6, SD: 2.19, %CV: 0.75
225 ng/mL	Mean Rate: 374, SD: 2.2, %CV: 0.6	Mean Rate: 374.4, SD: 3.01, %CV: 0.80
300 ng/mL	Mean Rate: 401, SD: 2.3, %CV: 0.6	Mean Rate: 399.8, SD: 3.42, %CV: 0.86
375 ng/mL	Mean Rate: 421, SD: 2.4, %CV: 0.6	Mean Rate: 421.8, SD: 3.20, %CV: 0.76
1000 ng/mL	- (Not reported)	Mean Rate: 530.8, SD: 5.17, %CV: 0.97
Within Run Precision (Semi-quantitative)			Comparable to predicate device; low %CVs.
225 ng/mL	Mean Conc: 226, SD: 6.0, %CV: 2.7	Mean Conc: 218.6, SD: 5.96, %CV: 2.73
300 ng/mL	Mean Conc: 303, SD: 8.1, %CV: 2.7	Mean Conc: 298.0, SD: 9.84, %CV: 3.30
375 ng/mL	Mean Conc: 379, SD: 15.1, %CV: 4.0	Mean Conc: 373.3, SD: 11.18, %CV: 3.00
Run-To-Run Precision (Qualitative)			Comparable to predicate device; low %CVs.
Negative	- (Not reported directly, but implied low)	Mean Rate: 292.8, SD: 1.81, %CV: 0.62
225 ng/mL	Mean Rate: 374, SD: 2.6, %CV: 0.7	Mean Rate: 375.8, SD: 3.61, %CV: 0.96
300 ng/mL	Mean Rate: 401, SD: 3.2, %CV: 0.8	Mean Rate: 400.8, SD: 3.34, %CV: 0.83
375 ng/mL	Mean Rate: 421, SD: 3.0, %CV: 0.7	Mean Rate: 421.1, SD: 2.87, %CV: 0.68
1000 ng/mL	- (Not reported)	Mean Rate: 528.6, SD: 4.84, %CV: 0.92
Run-To-Run Precision (Semi-quantitative)			Comparable to predicate device; low %CVs.
225 ng/mL	Mean Conc: 226, SD: 8.2, %CV: 3.6	Mean Conc: 223.8, SD: 9.45, %CV: 4.22
300 ng/mL	Mean Conc: 303, SD: 9.4, %CV: 3.1	Mean Conc: 301.0, SD: 9.15, %CV: 3.04
375 ng/mL	Mean Conc: 379, SD: 15.9, %CV: 4.2	Mean Conc: 377.8, SD: 7.53, %CV: 1.99
Sensitivity	6 ng/mL	15 ng/mL	Adequate sensitivity for intended use (difference noted, but deemed acceptable for substantial equivalence).
Accuracy	Vs. GC/MS: Positive Samples: 100% agreement, Negative Samples: 90% agreement	Vs. DRI® Opiate EIA (n = 216): Positive Samples: 97.1% agreement, Negative Samples: 93.8% agreement	Comparable to predicate device.
Analytical Recovery (Qualitative)	No data available	100% accuracy on positive vs. negative tests	Acceptable performance.
Analytical Recovery (Semi-quantitative)	No data available	Quantitates within ±10% of nominal concentration between 60-900 ng/mL.Average 97.7% recovery at 225 ng/mL (Cutoff - 25%)Average 96.7% recovery at 375 ng/mL (Cutoff + 25%)	Acceptable performance.
Interference	See predicate package insert	Compounds tested are comparable; results in specificity table	Comparable to predicate device.
Specificity	See predicate package insert	Comparable to the predicate device	Comparable to predicate device.

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

Sample Size for Accuracy Test: The accuracy study comparing the LZI device to the DRI® Opiate EIA used n = 216 samples.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

Accuracy Study: For the accuracy study against the predicate device, it's not clear that "experts" established a separate ground truth. The comparison was against the results of the DRI® Opiate EIA, which itself is a diagnostic test.
The predicate device's accuracy was established against GC/MS (Gas Chromatography/Mass Spectrometry), which is typically considered the gold standard for drug quantification. The document does not specify the number or qualifications of experts involved in the GC/MS analysis.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The comparison for accuracy was directly against the predicate device's results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic test, not an imaging or interpretive AI system that typically involves human readers.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the performance characteristics (precision, sensitivity, accuracy, analytical recovery, interference, specificity) described are for the device (immunoassay) operating in a standalone manner, providing analytical results without human real-time intervention during the analytical process itself. The interpretation of these results for clinical decisions would involve human judgment.

7. Type of Ground Truth Used

For the LZI device's accuracy study, the "ground truth" was effectively the results from the predicate device (DRI® Opiate EIA).
For the predicate device, its accuracy was established against GC/MS (Gas Chromatography/Mass Spectrometry), which serves as a definitive analytical "ground truth" for drug levels.

8. Sample Size for the Training Set

The document does not specify a training set sample size. Immunoassays are not "trained" in the typical machine learning sense with a distinct training dataset. Their performance is inherent in their chemical and biological design. The "studies" described are validation studies (testing) of the final device.

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

As there is no "training set" in the machine-learning sense for this immunoassay, this question is not applicable. The assay's performance characteristics are determined by its formulation and manufacturing, not by learning from a trained dataset.

Summary

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K020368

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

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

Device Name and Classification

Classification Name:	Opiate test system, Class II, DJG (91 Toxicology),21CFR 862.3650
Common Name:	Homogeneous enzyme immunoassay for the determinationof opiates levels in urine.
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.' Opiate Enzyme Immunoassay is substantially equivalent to the DRI® DAU Opiate Assay (By Microgenics Corp.), cleared under premarket notification K011150.

LZI's Opiate 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 Opiate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of opiates in human urine.

Comparison to Predicate Device

LZI's Opiate 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 DR1® Opiate Enzyme Immunoassay (K011150) by Microgenics Corporation.

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

Similarities:

. Both assays are for qualitative and semi-quantitative determination of opiates in human urine.
Both assays use the same method principle, and device components. ●
Both assays use 300 ng/mL as cutoff level per recommendations of The ● Substance Abuse and Metal Health Services Administration (SAMHSA).

Differences:

DRI® Opiate Enzyme Immunoassay can also be used as a 2000 ng/mL cutoff assay when different size of sample is used. Current LZI assay is for use as an assay with 300 ng/mL cutoff only.

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(Comparison to Predicate Device, continued)

Feature	Microgenics' DRI® Opiate EIA				LZI's Opiate EIA
Within Run Precision:
Qualitative:		Mean Rate	SD	% CV		Mean Rate	SD	% CV
	Negative	-	-	-	Negative	291.6	2.19	0.75
	225 ng/mL	374	2.2	0.6	225 ng/mL	374.4	3.01	0.80
	300 ng/mL	401	2.3	0.6	300 ng/mL	399.8	3.42	0.86
	375 ng/mL	421	2.4	0.6	375 ng/mL	421.8	3.20	0.76
	1000 ng/mL	-	-	-	1000 ng/mL	530.8	5.17	0.97
Semi-quantitative:		Mean Conc.	SD	% CV		Mean Conc.	SD	% CV
	225 ng/mL	226	6.0	2.7	225 ng/mL	218.6	5.96	2.73
	300 ng/mL	303	8.1	2.7	300 ng/mL	298.0	9.84	3.30
	375 ng/mL	379	15.1	4.0	375 ng/mL	373.3	11.18	3.00
Run-To-Run Precision:	(total precision)
Qualitative:		Mean Rate	SD	% CV		Mean Rate	SD	% CV
	Negative	-	-	-	Negative	292.8	1.81	0.62
	225 ng/mL	374	2.6	0.7	225 ng/mL	375.8	3.61	0.96
	300 ng/mL	401	3.2	0.8	300 ng/mL	400.8	3.34	0.83
	375 ng/mL	421	3.0	0.7	375 ng/mL	421.1	2.87	0.68
	1000 ng/mL	-	-	-	1000 ng/mL	528.6	4.84	0.92
Semi-quantitative:		Mean Conc.	SD	% CV		Mean Conc.	SD	% CV
	225 ng/mL	226	8.2	3.6	225 ng/mL	223.8	9.45	4.22
	300 ng/mL	303	9.4	3.1	300 ng/mL	301.0	9.15	3.04
	375 ng/mL	379	15.9	4.2	375 ng/mL	377.8	7.53	1.99
Sensitivity:	6 ng/mL				15 ng/mL
Accuracy:	Vs. GC/MS				Vs. DRI® Opiate EIA (n = 216)
	Positive Samples: 100 % agreement				97.1 % agreement
	Negative Samples: 90 % agreement				93.8 % agreement
Analytical Recovery:
	Qualitative: No data available				100 % accuracy on positive vs. negative tests
	Semi-quantitative: No data available				Quantitates within ±10% of the nominal
	concentration between 60ng/mL and 900
	ng/mL.
				Average 97.7 % recovery at 225 ng/mL level(Cutoff - 25%)
				Average 96.7 % recovery at 375 ng/mL level
	(Cutoff + 25%)
Interference:	See attached Microgenics' DRI® OpiateEIA package insert				Compounds tested are comparable to thepredicate device. Results included in thespecificity table.
Specificity:	See attached Microgenics' DRI® OpiateEIA package insert				Comparable to the predicate device.

Performance Characteristics (Comparing the 300 ng/mL cutoff assay performance only)

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Conclusion

LZI's Opiate 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 Opaite Enzyme Immunoassay to other opiate 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and head. The eagle faces to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

IUN 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: K020368

Trade/Device Name: Opiate Enzyme Immunoassay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG 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, 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 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 entifled. "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/dsmaldsmamain.html".

Sincerely yours.

Steven Butman

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): _ KO20368

Device Name: Opiate Enzyme Immunoassay

Indications for Use:

The Opiate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of opiates in human urine.

Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020368

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).