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.

AI/ML Overview

The provided text is a 510(k) summary for the Lin-Zhi International, Inc.'s Propoxyphene Enzyme Immunoassay. It describes the device, its intended use, and a comparison to a predicate device, along with performance characteristics. However, it does not provide detailed acceptance criteria in the typical format of a threshold that needs to be met (e.g., "sensitivity must be >90%"). Instead, it presents performance data for the new device alongside information from the predicate device (or states "No data available" for the predicate). The "acceptance criteria" are implied by the comparison to the predicate device and the conclusion that results were "acceptable."

Therefore, the table below reflects what can be extracted. Points 2 through 9 of your request cannot be fully answered from this document because it describes an in vitro diagnostic (IVD) assay, not a medical device that undergoes a typical "study" with a "test set" and "ground truth established by experts" in the way one might evaluate an AI/imaging device. The performance characteristics for IVD assays primarily focus on analytical performance like precision, sensitivity, accuracy against a reference method (like GC/MS), and specificity (cross-reactivity).

Acceptance Criteria and Device Performance

Feature	Acceptance Criteria (Implied by Predicate/General IVD Standards)	Reported Device Performance (LZI's Propoxyphene EIA)
Within Run Precision (Qualitative):	Comparable to predicate device's %CVs (e.g., around 1%) for various concentrations.	Negative: Mean Rate 117.4, SD 0.5, %CV 0.47 225 ng/mL: Mean Rate 225.1, SD 1.3, %CV 0.59 300 ng/mL: Mean Rate 261.3, SD 1.6, %CV 0.61 375 ng/mL: Mean Rate 287.7, SD 1.5, %CV 0.51 1000 ng/mL: Mean Rate 350.0, SD 1.4, %CV 0.39
Within Run Precision (Semi-quantitative):	Acceptable precision for quantitative measurements. (No predicate data for direct comparison; implied by overall "acceptable results").	225 ng/mL: Mean Conc. 231.3, SD 3.1, %CV 1.34 300 ng/mL: Mean Conc. 299.6, SD 5.8, %CV 1.92 375 ng/mL: Mean Conc. 379.7, SD 5.6, %CV 1.46
Run-To-Run Precision (Qualitative):	Comparable to predicate device's %CVs (e.g., around 1%) for various concentrations.	Negative: Mean Rate 116.8, SD 1.0, %CV 0.88 225 ng/mL: Mean Rate 220.8, SD 2.4, %CV 1.07 300 ng/mL: Mean Rate 255.9, SD 2.1, %CV 0.81 375 ng/mL: Mean Rate 285.1, SD 2.2, %CV 0.76 1000 ng/mL: Mean Rate 349.5, SD 1.9, %CV 0.55
Run-To-Run Precision (Semi-quantitative):	Acceptable precision for quantitative measurements. (No predicate data for direct comparison; implied by overall "acceptable results").	225 ng/mL: Mean Conc. 232.6, SD 3.0, %CV 1.27 300 ng/mL: Mean Conc. 298.7, SD 4.7, %CV 1.56 375 ng/mL: Mean Conc. 378.0, SD 7.4, %CV 1.97
Sensitivity:	Comparable to predicate device's sensitivity (15 ng/mL).	7.5 ng/mL (Better than predicate)
Accuracy (Qualitative):	High agreement with a commercial EIA and 100% confirmation of positives by GC/MS.	Vs. GC/MS: 100% agreement between positive samples flagged by the device and GC/MS. (Matches accuracy expectation for confirmatory method)
Analytical Recovery (Qualitative):	100% accuracy on positive vs. negative tests.	100% accuracy on positive vs. negative tests. (Meets criterion)
Analytical Recovery (Semi-quantitative):	Quantitate within ±10% of the nominal concentration between 30 ng/mL and 900 ng/mL.	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%). (Meets criterion)
Specificity:	Comparable to the predicate device's specificity.	Comparable to the predicate device. (Stated as comparable, specifics not provided in summary for the new device, but implied as acceptable via comparison to predicate's package insert).

Study Details (as inferable from the document for this IVD device):

Sample size used for the test set and the data provenance:
- Accuracy (Qualitative): 57 positive samples were confirmed by GC/MS. The total number of samples compared against a commercial EIA was 126.
- Provenance: Not explicitly stated, but typically clinical laboratory samples. No country of origin specified. Retrospective/Prospective not specified, but likely retrospective testing of banked samples or samples collected for validation.
- Precision and Analytical Recovery: Not specified but typically involves multiple replicates of spiked samples and controls.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical sense for this IVD device. The "ground truth" for chemical analysis like this is established by a reference method.
- Reference Method for Accuracy: Gas Chromatography/Mass Spectrometry (GC/MS) is cited as the preferred confirmatory method and was used for a portion of the accuracy study. GC/MS is an analytical chemistry technique, not an expert review.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The "ground truth" is determined by a definitive analytical method (GC/MS).
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:
- Not applicable. This is an in vitro diagnostic assay for drug detection, not an imaging or AI-driven diagnostic device that involves human readers/interpreters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone assay (chemical test), not an algorithm. Its performance is determined by the chemical reactions and spectrophotometric measurements. There is no "human-in-the-loop" performance component beyond interpreting the assay's final quantitative or qualitative result, which is common for all lab tests. The device itself performs the analysis without human interpretation of raw data beyond reading the instrument output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for accuracy was established using a reference analytical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS).
The sample size for the training set:
- Not applicable. As a chemical immunoassay, there is no "training set" in the machine learning sense. The assay is developed based on chemical principles and optimized through reagent formulation and calibration.
How the ground truth for the training set was established:
- Not applicable. No "training set" in the machine learning sense. The assay's performance characteristics are inherent to its chemical design. Calibration would have used known concentration standards.

Summary

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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

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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.

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(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 assayswere 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 nominalconcentration between 30 ng/mL and 900ng/mL.
				Average 104.9 % recovery at 225 ng/mLlevel (Cutoff -25%)
				Average 103.8 % recovery at 375 ng/mLlevel (Cutoff + 25%)
Specificity:	See attached DRI's Propoxyphene EIApackage insert			Comparable to the predicate device.

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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.

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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).

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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

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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

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).