The Propoxyphene assay is used for the qualitative analysis of propoxyphene in human urine with a cutoff of 300 ng/mL for used a clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose. The Propoxyphene assay is calibrated with propoxyphene and will detect propoxyphene and metabolites and analogs. The Propoxyphene assay provides only a preliminary analytical test result. A more specific alternate chemical method must be in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

Device Description

Propoxyphene is an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine. The assay is a homogeneous enzyme, immunoassay with a 300 ng/ml, cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.

AI/ML Overview

The provided text describes the Propoxyphene assay, an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine. The study conducted aims to demonstrate its substantial equivalence to the Emit® II Propoxyphene assay (K923873).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the Propoxyphene assay in a tabular format with numerical targets. Instead, it defines the performance characteristics and demonstrates substantial equivalence to a predicate device. The primary performance metric reported is concordance (agreement) with the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (Propoxyphene assay)
Substantial equivalence to Emit® II Propoxyphene assay	Concordance with Emit® II Propoxyphene assay: 99% agreement
Acceptable correlation with Emit® II Propoxyphene assay	"Acceptable correlation"
Agreement with GC/MS (confirmatory method)	"Agreement with GC/MS"
Precision (for Verifier I, Cutoff Calibrator, Verifier II, ±25% Controls)	Total %CV for Verifier I: 1.25% Total %CV for Cutoff Calibrator: 1.49% Total %CV for Verifier II: 1.19% Total %CV for -25% Control of Cutoff Calibrator: 2.39% Total %CV for +25% Control of Cutoff Calibrator: 1.90%
Cutoff concentration	300 ng/mL
Limit of Detection (Sensitivity)	60 ng/mL

Note on "Acceptance Criteria": For substantial equivalence claims, the acceptance criteria are often implicitly tied to demonstrating that the new device performs "as well as" or "similarly to" the predicate device for its intended use. Here, 99% agreement with the predicate device appears to be the key performance indicator used to support substantial equivalence.

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

Sample Size for Test Set: Not explicitly stated as a single number for the comparative performance study. The text mentions "The clinical specimens tested ranged from 404 to 56,662 ng/mL," implying that multiple clinical specimens were used. However, the exact number tested for the 99% concordance is not provided.
Data Provenance: Not specified (e.g., country of origin). The study used "clinical specimens." It is not stated whether the data was retrospective or prospective, but clinical specimens usually imply retrospective collection for such comparative studies.

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

Number of Experts: Not applicable. For this type of in vitro diagnostic assay, the "ground truth" for the test set is established by a reference method, not by human experts.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The ground truth is established by a reference method (GC/MS for confirmatory analysis, and the predicate device for comparative performance), not by a consensus of experts. Discrepancies between the new device and the predicate device were resolved by GC/MS (e.g., the one discordant sample was confirmed by GC/MS).

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

MRMC Study: No, this is an in vitro diagnostic device for analyte detection, not an imaging analysis or decision support system that involves human readers interpreting cases. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study is not relevant here.

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

Standalone Performance: Yes, the device's performance characteristics (e.g., concordance, precision, cutoff, limit of detection) are reported for the instrument-based assay itself, operating without human interpretation of the primary result. The assay generates a qualitative result (positive/negative) based on spectrophotometric measurements. The phrase "qualitative analysis" refers to the output of the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth:
- For the comparative study assessing agreement, the Emit® II Propoxyphene assay (predicate device) was used as a reference for initial comparison.
- For resolving discrepancies and confirming concentrations, GC/MS (Gas Chromatography/Mass Spectrometry) was used, which is considered the "gold standard" confirmatory method for drug testing.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not provided. This document describes the performance of a developed assay for regulatory submission, not the development process involving a separate training set for a machine learning model. Immunoassays are not "trained" in the machine learning sense; rather, they are designed and optimized based on chemical and biological principles.

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

Ground Truth for Training Set: Not applicable. As mentioned above, this is an immunoassay, not a machine learning model, so there isn't a "training set" with ground truth in the AI context. The assay's parameters would have been optimized through laboratory experimentation and validation, rather than learning from a labeled training dataset.

Summary

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SIU(K) Summarv

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 1-8 Irving, Texas 75038

MAR 2 0 2002 Contact Person Linda Morris Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary: November 21, 2001 Device Trade or Proprietary Name: Propoxyphene Device Common/Usual Name or Classification Name: Propoxyphene Classification Number/Class: JXN/Class fl

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 GFR 807:92.

The assigned 510(k) number is: K013100.

Test Description:

Propoxyphene is an in vitro diagnostic assay for the qualitative analysis of Propoxyphene in human urine. The assay is a homogeneous enzyme, immunoussay with a 300 ng/ml, cutoff. The assay is based on competition between drug in the specifien and drug labeled with the enzyne glucose-6-phosphate dehydrogenase (G6PDH) for antibody birtting sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, tesulting in an absorbance change that can be measured spectrophotometrically.

1. 1

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The Propoxyphene assay is substantially equivalent to the Emit® II Propoxyphene assay (K923873) on the SYVA®-30R Analyzer.

Both assays yield similar Performance Characteristics.

Similarities:

Both assays are in vitro immunoassays. •
. Both assays can be used for the qualitative analysis of Propoxyphene.
. Both assays yield similar results.
. Both assays are based on the competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
. Both assays have the same assay ranges (cutoff).

Differences:

The Propoxyphene assay is qualitative The Emit II Propoxyphene assay is qualitative and a semiquantitative.

Intended Use:

The Propoxyphene assay is used for the gralitative analysis of propoxyphene in human urine with a cutoff of 300 ng/mL. For use in clinical laboratories.

The Propoxyphene assay is calibrated with propoxyphene and will detect propoxyphene and its metabolites and analogs.

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Propoxyphicne assay method comparison yielded acceptable confelation with the Emit II Propox yphene assay on the SYVA-30R Analyzer. The concordance table for the Propoxyphene assay shows 99% agreement. One sample was positive using the Emit II Progoxybitene assay on the SYVA-30R Analyzer and negative using the Propoxyphene assay on the AEROSET System. This sample was shown to contain 404 ng/mL of norpropoxyphene determined by GMN. The Propoxyphene assay method comparison yielded

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agreement with GC/MS. The clinical speeimens tested ranged from 404 to 56,662 ng/ml.. Precision studies were conducted using the Propoxyobeneyassay. The total %CV for Verifier I is 1.25%. The total %CV for the Cutoff Calibrator is 1.49%; the total %CV for Verifier II is 1.19%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples are 2.39% and 1.90%, respectively. The Propoxyphene assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Propoxyphene assay is 60 ng/m]. Mess data demonstrate that the performance of the Propoxyphene assay is substantially edition to the performance of the Emit II Propoxyphene assay on the SYVA-30R Analyzer

Conclusion:

The Propoxyphene assay is substantially equivalent to the Emit II Propoxyphene assay on the SYVA-30R Analyzer as demonstrated by results optained in the studies.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 are three stylized human profiles facing to the right, stacked on top of each other.

MAR 2 0 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Linda Morris Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038

Re: K013100

Trade/Device Name: Propoxyhene Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: Class II Product Code: JXN Dated: November 26, 2001 Received: November 28, 2001

Dear Ms. Morris:

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 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/cdrb/dsma/dsmamain.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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510(k) Number (if known): K013100

Device Name: Propoxyphene

Indications For Use:

qualitative analysis of propoxyphene in human urir The Propoxyphene assay is used for with a cutoff of 300 ng/mL for used a cirfical laboratories. Measurements obtained by this device are used in the diagnosi; and treatinent of propoxyphene use or overdose.

The Propoxyphene assay is callbrated with propoxyphene and will detect propoxyphene an metabolites and analogs.

The Propoxyphene assay provides only a preliminary analytical test result. A more specific alternate chemical method must be in order to obtain a confirmed analytical result. G chromatography/mass spectronietry(GCAMS) is the prefected confirmatory method. Clinic consideration and professional judgment should be applied to any drug of abuse test result, sults are used. particularly when preliminary p

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	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_	Over-The-Counter Use_
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

(Division Sign-Off) Division of Clinical Laboratory Devices
Number	K013100 51

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).