Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone 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 methadone use or abuse. The proposed Abuscreen ONLINE Methadone 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 Methadone 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 provided text regarding the Abuscreen ONLINE® Methadone device, focusing on its acceptance criteria and the supporting study:

The document is a 510(k) summary for a medical device called "Abuscreen ONLINE® Methadone," an in vitro diagnostic test for detecting methadone in human urine. The submission date is October 20, 1998, and it was reviewed by the FDA, resulting in a substantial equivalence determination on December 11, 1998.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by the performance characteristics presented for the "Proposed: Abuscreen ONLINE Methadone for Hitachi 917" device, which are compared to a "Previously Cleared: (K930928) Abuscreen ONLINE Methadone (1000 Test Kit)" predicate device. The goal of the study is to demonstrate that the new device performs equivalently to the predicate.

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Proposed)
Qualitative Precision (300 ng/mL Cutoff):
Negative at 225 ng/mL	>95% negative at 240 ng/mL	>95% negative at 225 ng/mL
Positive at 375 ng/mL	>95% positive at 360 ng/mL	>95% positive at 375 ng/mL
Quantitative Precision (300 ng/mL Cutoff):
Within Run:
150 ng/mL Mean (ng/mL)	152	148
150 ng/mL CV%	4	2.4
225 ng/mL Mean (ng/mL)	235 (at 240 ng/mL conc.)	220
225 ng/mL CV%	3 (at 240 ng/mL conc.)	3.2
300 ng/mL Mean (ng/mL)	301	299
300 ng/mL CV%	1	1.5
375 ng/mL Mean (ng/mL)	340 (at 340 ng/mL conc.)	411
375 ng/mL CV%	1 (at 340 ng/mL conc.)	1.0
Day-to-Day:
150 ng/mL Mean (ng/mL)	151	151
150 ng/mL CV%	4	4.2
225 ng/mL Mean (ng/mL)	236 (at 240 ng/mL conc.)	222
225 ng/mL CV%	3 (at 240 ng/mL conc.)	3.7
300 ng/mL Mean (ng/mL)	297	303
300 ng/mL CV%	3	2.2
375 ng/mL Mean (ng/mL)	340 (at 340 ng/mL conc.)	407
375 ng/mL CV%	1 (at 340 ng/mL conc.)	2.0
Accuracy (300 ng/mL Cutoff):
Confirmed Positive results	73 Positive, 0 Negative (from N=73 Confirmed Pos.)	50 Positive, 0 Negative (from N=50 Confirmed Pos.)
Limit of Detection	< 15 ng/mL	19 ng/mL

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

The provided document refers to the data as "clinical and nonclinical tests," but it does not specify the provenance (e.g., country of origin) or whether the data was retrospective or prospective.

Accuracy Test Set Sample Size:
- N = 50 confirmed positive samples were used to evaluate accuracy for the proposed device (all 50 were reported as positive, 0 negative).
- For comparison, the predicate device had N = 73 confirmed positive samples (all 73 were reported as positive, 0 negative).
Precision Test Set Sample Size: The document lists "Within Run" and "Day-to-Day" precision data at different methadone concentrations (150, 225, 300, 375, 450 ng/mL). However, it does not explicitly state the number of replicate measurements or the total sample size for these precision studies. It only provides the mean and Coefficient of Variation (CV%).

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

The document does not provide information on the number of experts used, their qualifications, or how the ground truth was established for the "Accuracy" test set (where samples were "Confirmed Pos."). It implies a confirmed status, but the method of confirmation is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an imaging or interpretive AI system that typically involves human readers. The study compares the performance of the automated assay to a predicate automated assay.

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

Yes, a standalone performance study was done. The "Abuscreen ONLINE Methadone" device is an automated clinical chemistry analyzer test that detects methadone in urine. The performance characteristics described (precision, accuracy, limit of detection) are intrinsic to the device's analytical function without direct human interpretation in the results generation. Human involvement is limited to operating the analyzer and interpreting the final quantitative/qualitative results provided by the machine.

7. The Type of Ground Truth Used

The ground truth used for the accuracy study is referred to as "Confirmed Pos." for the samples. However, the method of confirmation (e.g., reference method like GC/MS, pathology, or clinical outcome data) is not specified in the provided text. For diagnostic tests, "confirmed positive" usually refers to confirmation by a more definitive or gold-standard method.

8. The Sample Size for the Training Set

The document does not provide information about a training set. This submission is for an in vitro diagnostic immunoassay, not a machine learning or AI-based device that typically undergoes a distinct training phase. These types of assays are developed and validated through laboratory testing to establish their analytical characteristics.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth was established.

Summary

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Image /page/0/Picture/1 description: The image shows the Roche logo. The logo consists of the word "Roche" written in black font inside of a hexagon. The hexagon is outlined in black.

510(k) Summary

Abuscreen ONLINE® Methadone

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:

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

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II. 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	ClassificationName	ProductCode	CFRNumber andRegulatory Class
Abuscreen ONLINE forMethadone	Enzyme Immunoassay,Methadone	DJR	862.3620Class 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.

Cable(211
---------------------------	--

Product Name	Predicate ProductName	510(k) Number and DatePredicate Cleared
Abuscreen ONLINE forMethadone	Abuscreen ONLINE forMethadone	K930928 /24/93

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

The proposed Abuscreen ONLINE Methadone 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 Methadone 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. Additional detailed information about the Hitachi 917 Analyzer is contained in volume II of the premarket notification (K953239) cleared on September 25, 1995.

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

Tables 3 outlines the technological characteristics (methodologies) of the Abuscreen ONLINE Methadone in comparison to that of the legally marketed predicate 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 Methadone. 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 Methadone for Hitachi 917 Table 3

	Proposed:			Previously Cleared: (K930928)
	Abuscreen ONLINE Methadone			Abuscreen ONLINE Methadone
	for Hitachi 917			(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 methadone			qualitative and semiquantitativedetection of methadone
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: methadonepolyclonal (goat) antibody inbuffer2. Microparticle reagent:Conjugated methadonederivative microparticles inbuffer3. Diluent: Buffer			1. Ab reagent: methadonepolyclonal (goat) antibody inbuffer2. Microparticle reagent:Conjugated methadonederivative microparticles inbuffer3. Diluent: Buffer
Performance Characteristics:
Precision Qualitative (300 ng/mL Cutoff):
	>95% negative at 225 ng/mL			>95% negative at 240 ng/mL
	>95% positive at 375 ng/mL			>95% positive at 360 ng/mLL
Within Run	Mean (OD)	CV%
150 ng/mL	5661	1.1
225 ng/mL	4437	1.9
300 ng/mL	3286	1.4
375 ng/mL	2205	1.9
450 ng/mL	1780	2.7
Day-to-Day	Mean (OD)	CV%
150 ng/mL	5541	3.2
225 ng/mL	4308	4.1
300 ng/mL	3212	3.7
375 ng/mL	2146	3.6
450 ng/mL	1749	4.4
Proposed:			Previously Cleared: (K930928)
Abuscreen ONLINE			Abuscreen ONLINE Methadone
Methadone 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	148	2.4	150	152	4
225 ng/mL	220	3.2	240	235	3
300 ng/mL	299	1.5	300	301	1
375 ng/mL	411	1.0	340	340	1
450 ng/mL	444	0.8
Day-to-Day	Mean (ng/mL)	CV%	Conc. (ng/mL)	Mean (ng/mL)	CV%
150 ng/mL	151	4.2	150	151	4
225 ng/mL	222	3.7	240	236	3
300 ng/mL	303	2.2	300	297	3
375 ng/mL	407	2.0	340	340	1
450 ng/mL	452	1.5
Accuracy
300 ng/mL Cutoff	N= 50 Confirmed Pos.50 Pos. 0 Neg.		N = 73 Confirmed Pos.73 Pos. 0 Neg.
Limit of Detection	19 ng/mL		< 15 ng/mL

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Abuscreen ONLINE Methadone for Hitachi 917 Table 3 (Continued)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEC 1 1 1998

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K983703 Abuscreen ONLINE® Methadone Assay Trade Name: Regulatory Class: İI Product Code: DJR 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 leqally 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 reqistration, 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 Regulation (QS) for Medical Devices: General regulation (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 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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of Page 1

510(k) Number (if known)

Device Name: Abuscreen ONLINE® Methadone

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. K983703

Regulation Number and Section

§ 862.3620 Methadone test system.

(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).