K Number

Device Name

PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)

Manufacturer

Lin-Zhi International, Inc.

Date Cleared

2003-01-21

(69 days)

Product Code

JXN

Regulation Number

862.3700

Intended Use

The Propoxyphene 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 propoxyphene in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Propoxyphene 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.

Device Description

LZI's Propoxyphene Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect propoxyphene in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between propoxyphene 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 convert nicotinamide adenine dinucleotide (NAD) to NADH.

More Information

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Center

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Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

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ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K943414

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric analysis. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No.
The device is an in vitro diagnostic test for propoxyphene in human urine, used for qualitative and semi-quantitative analysis. It is not designed to treat, prevent, or cure any disease or condition.

Diagnostic

Yes

The device is an immunoassay intended for qualitative and semi-quantitative analyses of propoxyphene in human urine, providing a preliminary analytical test result. This is a diagnostic function, as it helps identify the presence of a substance associated with a medical condition (drug use).

SaMD (Software as a Medical Device)

The device is a liquid reagent enzyme immunoassay, which is a chemical-based test kit, not a software-only device. It is intended for use with automated clinical chemistry analyzers, but the device itself is a physical reagent.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative analyses of propoxyphene in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (presence of propoxyphene).
Device Description: The description details a "homogeneous enzyme immunoassay" that uses specific antibodies to detect propoxyphene in human urine. This is a common method used in IVD devices for analyzing biological samples.
Anatomical Site: The specified anatomical site is "human urine," which is a biological specimen.
Intended User/Care Setting: It's designed for "professional use with a number of automated clinical chemistry analyzers," indicating it's used in a clinical or laboratory setting for diagnostic purposes.
Performance Studies and Key Metrics: The document includes information about performance characteristics like precision, sensitivity, accuracy, analytical recovery, and specificity, which are standard evaluations for IVD devices to demonstrate their reliability for diagnostic use.
Predicate Device: The mention of a "Predicate Device" (K943414; Propoxyphene Enzyme Immunoassay) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.

All these factors align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Propoxyphene 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.

Product codes

JXN

Device Description

The assay is based on competition between propoxyphene 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 convert nicotinamide adenine dinucleotide (NAD) to NADH.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional use with a number of automated clinical chemistry analyzers.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Feature	DRI's Propoxyphene EIA			LZI's Propoxyphene EIA
Within Run Precision:
Qualitative:	Mean Rate	SD	% CV	Mean Rate	SD	% CV
	Negative	153	-	1.1	Negative	117.4	0.5	0.47
	225 ng/mL	-	-	-	225 ng/mL	225.1	1.3	0.59
	300 ng/mL	265	-	1.0	300 ng/mL	261.3	1.6	0.61
	375 ng/mL	-	-	-	375 ng/mL	287.7	1.5	0.51
	1000 ng/mL	322	-	0.9	1000 ng/mL	350.0	1.4	0.39
Semi-quantitative:	No data available.				Mean Conc.	SD	% CV
					225 ng/mL	231.3	3.1	1.34
					300 ng/mL	299.6	5.8	1.92
					375 ng/mL	379.7	5.6	1.46
Run-To-Run Precision:
Qualitative:	Mean Rate	SD	% CV	Mean Rate	SD	% CV
	Negative	154	-	1.0	Negative	116.8	1.0	0.88
	225 ng/mL	-	-	-	225 ng/mL	220.8	2.4	1.07
	300 ng/mL	265	-	0.8	300 ng/mL	255.9	2.1	0.81
	375 ng/mL	-	-	-	375 ng/mL	285.1	2.2	0.76
	1000 ng/mL	324	-	0.9	1000 ng/mL	349.5	1.9	0.55
Semi-quantitative:	No data available.				Mean Conc.	SD	% CV
					225 ng/mL	232.6	3.0	1.27
					300 ng/mL	298.7	4.7	1.56
					375 ng/mL	378.0	7.4	1.97
Sensitivity:	15 ng/mL			7.5 ng/mL
Accuracy:	Vs. a commercial EIA:			Vs. GC/MS
	116/126 in agreement			100 % agreement
	All 57 positive samples by both assays
were confirmed by GC/MS.			100 % agreement
Analytical Recovery:
	Qualitative: No data available			100 % accuracy on positive vs. negative tests
	Semi-quantitative: No data available			Quantitate within ±10% of the nominal
concentration between 30 ng/mL and 900
ng/mL.
				Average 104.9 % recovery at 225 ng/mL
level (Cutoff -25%)
				Average 103.8 % recovery at 375 ng/mL
level (Cutoff + 25%)
Specificity:	See attached DRI's Propoxyphene EIA
package insert			Comparable to the predicate device.

All the studies showed acceptable results when compared to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K943414

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.3700 Propoxyphene test system.

(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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).

Summary

K023795
JAN 21 2003

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 (408) 944-0359 Fax:

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

Device Name and Classification

Classification Name:	Enzyme Immunoassay, Propoxyphene, Class II, JXN (91 Toxicology), 21CFR 862.3700
Common Name:	Homogeneous enzyme immunoassay for the determination of propoxyphene level in urine.
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.' Propoxyphene Enzyme Immunoassay is substantially equivalent to the Propoxyphene Enzyme Immunoassay (By DRI/Microgenics Corp.), cleared under premarket notification K943414.

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

Device Description

Intended Use

Comparison to Predicate Device

LZI's Propoxyphene 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 Propoxyphene Enzyme Immunoassay (K943414) by Diagnostic Reagents, Inc. (DRI, now Microgenics Corporation)

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

Similarities:

Both assays are for qualitative and semi-quantitative determination of . propoxyphene in human urine.
Both assays use the same method principle, and device components. .
Both assays use 300 ng/mL as cutoff level. .

Differences:

· LZI's Propoxyphene Enzyme Immunoassay uses 5 calibrators for the semiquantitative analysis of propoxyphene concentration in urine. DRI's Propoxyphene EIA used 3 calibrators previously. A total of 5 calibrators are available now from DRI in the "Multi-drug Urine Calibrators and Controls" product.

(Comparison to Predicate Device, continued)

Performance Characteristics

Feature	DRI's Propoxyphene EIA			LZI's Propoxyphene EIA
Within Run Precision:
Qualitative:	Mean Rate	SD	% CV	Mean Rate	SD	% CV
	Negative	153	-	1.1	Negative	117.4	0.5	0.47
	225 ng/mL	-	-	-	225 ng/mL	225.1	1.3	0.59
	300 ng/mL	265	-	1.0	300 ng/mL	261.3	1.6	0.61
	375 ng/mL	-	-	-	375 ng/mL	287.7	1.5	0.51
	1000 ng/mL	322	-	0.9	1000 ng/mL	350.0	1.4	0.39
Semi-quantitative:	No data available.				Mean Conc.	SD	% CV
				225 ng/mL	231.3	3.1	1.34
				300 ng/mL	299.6	5.8	1.92
				375 ng/mL	379.7	5.6	1.46
Run-To-Run Precision:
Qualitative:	Mean Rate	SD	% CV	Mean Rate	SD	% CV
	Negative	154	-	1.0	Negative	116.8	1.0	0.88
	225 ng/mL	-	-	-	225 ng/mL	220.8	2.4	1.07
	300 ng/mL	265	-	0.8	300 ng/mL	255.9	2.1	0.81
	375 ng/mL	-	-	-	375 ng/mL	285.1	2.2	0.76
	1000 ng/mL	324	-	0.9	1000 ng/mL	349.5	1.9	0.55
Semi-quantitative:	No data available.				Mean Conc.	SD	% CV
				225 ng/mL	232.6	3.0	1.27
				300 ng/mL	298.7	4.7	1.56
				375 ng/mL	378.0	7.4	1.97
Sensitivity:	15 ng/mL			7.5 ng/mL
Accuracy:	Vs. a commercial EIA:			Vs. GC/MS
	116/126 in agreement			100 % agreement
	All 57 positive samples by both assays
were confirmed by GC/MS.			100 % agreement
Analytical Recovery:
	Qualitative: No data available			100 % accuracy on positive vs. negative tests
	Semi-quantitative: No data available			Quantitate within ±10% of the nominal
concentration between 30 ng/mL and 900
ng/mL.
				Average 104.9 % recovery at 225 ng/mL
level (Cutoff -25%)
				Average 103.8 % recovery at 375 ng/mL
level (Cutoff + 25%)
Specificity:	See attached DRI's Propoxyphene EIA
package insert			Comparable to the predicate device.

Conclusion

LZI's Propoxyphene 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 Propoxyphene Enzyme Immunoassay to other propoxyphene test systems currently marketed in the United States.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 1 2003

Chiu Chin Chang, Ph.D. VP. R&D Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085-2917

Re: K023795

Trade/Device Name: Propoxyphene Enzyme Immunoassay Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: Class II Product Code: JXN Dated: November 11, 2002 Received: November 13, 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2 –

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Premarket Notification

Indications for Use Statement

510(k) Number (if known):

Device Name: Propoxyphene Enzyme Immunoassay

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Sean Cooper

(Optional Format 1Quession Sign-C visión of Clinical I 510(k) Number