Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of propoxyphene use or abuse.

Device Description

The proposed Abuscreen ONLINE Propoxyphene test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Propoxyphene test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. This modified test kit is not a replacement to the currently marketed kit.

The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the Abuscreen ONLINE® Propoxyphene device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abuscreen ONLINE® Propoxyphene device can be inferred by comparing its performance to that of its legally marketed predicate device (K945195). The study demonstrates that the new device performs equivalently to the predicate.

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Proposed Device)
Precision Qualitative	>95% negative at 240 ng/mL>95% positive at 360 ng/mL	>95% negative at 225 ng/mL>95% positive at 375 ng/mL
Precision Quantitative (Within Run)	Representative values from K945195:200 ng/mL: 208 ng/mL (3% CV)250 ng/mL: 262 ng/mL (2% CV)300 ng/mL: 292 ng/mL (1% CV)340 ng/mL: 329 ng/mL (1% CV)	150 ng/mL: 153 ng/mL (2.0% CV)225 ng/mL: 239 ng/mL (1.3% CV)300 ng/mL: 306 ng/mL (1.6% CV)375 ng/mL: 440 ng/mL (1.0% CV)450 ng/mL: 473 ng/mL (0.6% CV)
Precision Quantitative (Day-to-Day)	Representative values from K945195:200 ng/mL: 208 ng/mL (3% CV)250 ng/mL: 262 ng/mL (2% CV)300 ng/mL: 293 ng/mL (1% CV)340 ng/mL: 331 ng/mL (1% CV)	150 ng/mL: 147 ng/mL (5.2% CV)225 ng/mL: 236 ng/mL (3.1% CV)300 ng/mL: 302 ng/mL (2.4% CV)375 ng/mL: 435 ng/mL (2.4% CV)450 ng/mL: 467 ng/mL (1.2% CV)
Accuracy (300 ng/mL Cutoff)	N= 63 Confirmed Pos. 63 Pos.0 Neg.	N= 50 Confirmed Pos.50 Pos.0 Neg.
Limit of Detection	30 ng/mL	0 ng/mL

Study Proving Device Meets Acceptance Criteria:

The study described is a non-clinical evaluation comparing the "Abuscreen ONLINE Propoxyphene for Hitachi 917" (the proposed device) against the "Abuscreen ONLINE Propoxyphene (1000 Test Kit)" (the predicate device, K945195). The study aims to demonstrate substantial equivalence based on performance characteristics.

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

Sample Size for Qualitative Precision: The document states that for the qualitative precision at 300 ng/mL cutoff, the proposed device showed:
- ">95% negative at 225 ng/mL" and ">95% positive at 375 ng/mL". This implies multiple samples were tested at these concentrations to achieve statistical significance for the percentages reported, but the exact number of individual samples is not explicitly given.
Sample Size for Quantitative Precision: The within-run and day-to-day precision data are presented as Mean (OD) and CV% for Optical Density (OD) values and Mean (ng/mL) and CV% for concentration values at various propoxyphene levels (150, 225, 300, 375, 450 ng/mL). The number of replicates or runs to calculate these means and CVs is not explicitly stated.
Sample Size for Accuracy:
- Proposed device: N= 50 Confirmed Pos. (meaning 50 samples with confirmed positive results were tested).
Data Provenance: Not explicitly stated. Given the context of a 510(k) submission from Roche Diagnostic Systems, Inc. in New Jersey, USA, it's highly probable the data was generated in the United States, likely in a laboratory setting or using banked samples. The study is retrospective in the sense that it evaluates the performance of the developed device against established predicate performance.

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

Not Applicable: This type of device (in vitro diagnostic for drug detection) does not typically involve expert review of images or clinical assessments to establish ground truth in the same way as, for example, a radiology AI device. The ground truth for such assays is established through analytical methods, often using reference standards or confirmed positive/negative samples.

4. Adjudication Method

Not Applicable: As mentioned above, this device does not involve human interpretation or subjective assessment that would require an adjudication method. The results are quantitative or qualitative measurements from an automated clinical chemistry analyzer.

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

No: This is not relevant for this type of in vitro diagnostic device. MRMC studies are typically used for imaging AI devices that assist human readers in tasks like lesion detection or diagnosis. This device provides a direct analytical measurement.

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

Yes: The entire study described focuses on the standalone performance of the "Abuscreen ONLINE Propoxyphene for Hitachi 917" test kit (the proposed device) as an automated assay. It measures its analytical performance characteristics directly, without a human in the diagnostic loop to interpret the results from the device itself. The device directly outputs qualitative or semi-quantitative measurements.

7. Type of Ground Truth Used

The ground truth for the test set is established by the confirmed concentration of propoxyphene and its metabolites in urine samples. For accuracy, it relies on "Confirmed Pos." samples, implying independent verification of the presence of the drug at or above the cutoff. For precision, it uses samples spiked or prepared to precise known concentrations.

8. Sample Size for the Training Set

Not explicitly stated: This document describes a 510(k) submission for a new formulation of an existing immunoassay to be run on a specific analyzer. Immunoassays are based on biochemical interactions, not machine learning algorithms that require explicit "training sets" in the computational sense. The "training" for such a device involves optimizing reagent concentrations, reaction conditions, and calibration curves during its development. The text implies the device was "adapted from the currently marketed Abuscreen ONLINE Propoxyphene test kit," suggesting that the underlying assay principles and initial development would have been established previously.

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

Not explicitly stated/Not Applicable in the AI/ML sense: As above, this is an immunoassay, not an AI/ML model. The "ground truth" during the development and optimization of such an assay (analogous to a training set) would involve extensive analytical experiments using:
- Reference standards of propoxyphene and its metabolites at known concentrations.
- Characterized positive and negative urine samples.
- Samples with known interfering substances.
- The goal of this "training" phase is to ensure the assay reagents and conditions provide accurate and precise measurements across the intended dynamic range and specificity.

Summary

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DEC 1 1 1998

1983700

Roche

510(k) Summary

Abuscreen ONLINE® Propoxyphene

In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.

The assigned 510(k) number is:

Identification of 510(k) Sponsor: I.

Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

510(k) Submission dated October 20, 1998

Rita Smith Contact: Senior Regulatory Affairs Associate Phone: (908) 253-7545 (908) 253-7547 Fax:

Roche Diagnostic Systems, Inc.

Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

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and the comments of the comments of the comments of the comments of

【】. Device Name:

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

Table 1

Product Name	Classification Name	Product Code	CFR Number andRegulatory Class
Abuscreen ONLINE forPropoxyphene	Enzyme Immunoassay,Propoxyphene	JXN	862.3700Class II

III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

ableC1	V
----------------	---

Product Name	Predicate ProductName	510(k) Number and DatePredicate Cleared
Abuscreen ONLINE forPropoxyphene	Abuscreen ONLINE forPropoxyphene	K945195 12/9/94

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IV. Description of the Device/Statement of Intended Use:

V. Summary of the technological characteristics of the new device in comparison to those of the predicate.

Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Propoxyphene in comparison to that of the legally marketed product.

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Brief discussion of the clinical and nonclinical tests relied on for a determination of VI. substantial equivalence:

Tables 3 demonstrates the results of clinical and nonclinical studies performed using the Abuscreen ONLINE Propoxyphene test. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device.

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Abuscreen ONLINE Propoxyphene for Hitachi 917 Table 3

	Proposed:		Previously Cleared: (K945195)
	Abuscreen ONLINE		Abuscreen ONLINE
		Propoxyphene for Hitachi 917	Propoxyphene (1000 Test Kit)
Methodology	Kinetic interaction ofmicroparticles in a solution asmeasured by changes in lighttransmission		Kinetic interaction ofmicroparticles in a solution asmeasured by changes in lighttransmission
Sample type	urine		urine
Intended Use	qualitative and semiquantitativedetection of propoxyphene andits metabolites		qualitative and semiquantitativedetection of propoxyphene andits metabolites
Calibrator	Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3		Abuscreen ONLINE CalibrationPack or Abuscreen ONLINECalibrator Level 3
Cutoff(s)	300 ng/mL		300 ng/mL
Reagent (activeingredients)	1. Ab reagent: propoxyphenepolyclonal (goat) antibody inbuffer2. Microparticle reagent:Conjugated propoxyphenederivative microparticles inbuffer3. Diluent: Buffer		1. Ab reagent: propoxyphenepolyclonal (goat) antibody inbuffer2. Microparticle reagent:Conjugated propoxyphenederivative microparticles inbuffer3. Diluent: Buffer
Performance Characteristics:
Precision Qualitative (300 ng/mL Cutoff):
	>95% negative at 225 ng/mL>95% positive at 375 ng/mL		>95% negative at 240 ng/mL>95% positive at 360 ng/mL
Within Run	Mean (OD)	CV%
150 ng/mL	6177	3.8
225 ng/mL	4247	2.2
300 ng/mL	3082	3.2
375 ng/mL	1710	4.9
450 ng/mL	1383	1.6
Day-to-Day	Mean (OD)	CV%
150 ng/mL	6015	3.3
225 ng/mL	4183	4.2
300 ng/mL	2988	3.9
375 ng/mL	1749	4.0
450 ng/mL	1433	4.7
	Proposed:		Previously Cleared: (K945195)
	Abuscreen ONLINE		Abuscreen ONLINE Propoxyphene
		Propoxyphene for Hitachi 917		(1000 Test Kit)
Precision Quantitative ( 300 ng/mL Cutoff ):
Within Run	Mean (ng/mL)	CV%	Conc. (ng/mL)	Mean (ng/mL)	CV%
150 ng/mL	153	2.0	200	208	3
225 ng/mL	239	1.3	250	262	2
300 ng/mL	306	1.6	300	292	1
375 ng/mL	440	1.0	340	329	1
450 ng/mL	473	0.6
Day-to-Day	Mean (ng/mL)	CV%	Conc. (ng/mL)	Mean (ng/mL)	CV%
150 ng/mL	147	5.2	200	208	3
225 ng/mL	236	3.1	250	262	2
300 ng/mL	302	2.4	300	293	1
375 ng/mL	435	2.4	340	331	1
450 ng/mL	467	1.2
Accuracy
300 ng/mL Cutoff	N= 50 Confirmed Pos.		N = 63 Confirmed Pos.
	50 Pos.0 Neg.		63 Pos. 0 Neg.
Limit of Detection	0 ng/mL		30 ng/mL

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.. .

Abuscreen ONLINE Propoxyphene for Hitachi 917 Table 3 (Continued)

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Image /page/6/Picture/2 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 is a stylized graphic of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

DEC 1 1 1998

Ms. Rita Smith Senior Requlatory Affairs Associate Roche Diaqnostic Systems, Inc. A Subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K983700 Abuscreen ONLINE® Propoxyphene Assay Trade Name: Requlatory Class: II Product Code: JXN Dated: October 20, 1998 Received: October 21, 1998

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Radioloqical Health

Enclosure

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Page 1 of

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Propoxyphene

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical Laboratory Devices-
510(k) Number K983700

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).