The Beckman SYNCHRON Systems Methadone Reagent, in conjunction with the SYNCHRON Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 nq/mL, on SYNCHRON Systems.

Device Description

The SYNCHRON Methadone Reagent, in conjunction with the SYNCHRON CX Drugs of Abuse Testing Urine Calibrators, is intended for the qualitative determination of methadone in human urine, at a cutoff value of 300 ng/mL, on SYNCHRON Systems.

AI/ML Overview

The provided text describes a 510(k) submission for the Beckman SYNCHRON Systems Methadone (METD) Reagent. This submission aims to demonstrate substantial equivalence to a predicate device, focusing on a new formulation of the reagent.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the submission relies on demonstrating "substantial equivalence" to a predicate device, particularly regarding "safety and effectiveness."

The primary performance aspect discussed is the specificity of the monoclonal antibody.

Acceptance Criteria (Implied)	Reported Device Performance
Specificity of new monoclonal antibody formulation	Specific only to methadone
Stability	12 months at 4°C and 60 days on a SYNCHRON instrument
Equivalence to Predicate Device	Same intended use, chemical reaction, calibration, reagent kit configuration, product part number.

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

The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "data in the Premarket Notification" that supports substantial equivalence.

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

The document does not mention using experts to establish ground truth for any test set, nor does it refer to their number or qualifications.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set.

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

The document does not mention an MRMC comparative effectiveness study, nor does it discuss human readers or AI assistance. This device is a diagnostic reagent, an in-vitro diagnostic (IVD), not an AI-powered diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

As this is a diagnostic reagent (IVD) and not an AI algorithm, the concept of "standalone (algorithm only)" performance does not directly apply in the typical sense of AI-based diagnostics. The performance described relates to the reagent's analytical characteristics. The provided text does not detail specific standalone performance studies in terms of diagnostic accuracy metrics. It only states that the new formulation is "specific only to methadone."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given the nature of a methadone test system, the "ground truth" would typically be established by highly accurate confirmatory methods like GC/MS (which is mentioned as the preferred confirmatory method for positive results). However, the document doesn't explicitly state that these methods were used to establish the ground truth for the performance data submitted.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a characteristic typically associated with machine learning or AI models, which is not applicable to this diagnostic reagent submission.

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

Since no training set is mentioned (as this is not an AI/ML device), there is no information on how ground truth for a training set was established.

Summary

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Methadone (METD) Reagent Summary of Safety & Effectiveness

K973069

Summary of Safety & Effectiveness Beckman SYNCHRON Systems Methadone Reagent

1.0 Submitted By:

Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457

2.0 Date Submitted:

14 August 1997

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Methadone Reagent

3.2 Classification Name

Methadone Test System (21 CFR § 862.3620)

4.0 Predicate Device(s):

BECKMAN Reagent	Predicate	Predicate Company	Docket Number
SYNCHRON SystemsMethadone	SYNCHRON SystemsMethadone	BeckmanInstruments, Inc.	K9944074

5.0 Description:

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Intended Use: 6.0

The Beckman Methadone assay provides a rapid screening procedure for determining the presence of methadone in urine. The test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatograph/mass spectrometry (GC/MS). 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 positive results are used.

7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
SYNCHRONSystems Methadone(METD) Reagent	Intended use	Same as the predicate
	Chemical Reaction	Same principle as the predicate
	Calibration	Same as the predicate
	Reagent Kit Configuration	Same as the predicate
	Product Part Number	Same as the predicate

SIMILARITIES to the PREDICATE

DIFFERENCES from the PREDICATE

Reagent	Aspect/Characteristic	Comments
SYNCHRONSystemsMethadone(METD) Reagent	Specificity of monoclonalantibody	Current Formulation:Specific to both methadone and LAMM
		New Formulation:Specific only to methadone

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence of the new SYNCHRON Methadone formulation vs the current formulation . Stress stability studies of the Methadone reagent support the Beckman stability claim of 12 months at 4°C and 60 days on a SYNCHRON instrument.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing requiration 21 CFR 807.92.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font.

SEP 2 2 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, CA 92622-8000

K973069/S1 Re : SYNCHRON® Systems Methadone Reagent Requlatory Class: II Product Code: DJR September 8, 1997 Dated: September 10, 1997 Received:

Dear Ms. Stockert:

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 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 The general controls provisions of the Act 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 requlations 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 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 regulatory In addition, FDA may publish further announcements action. 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 requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chill ou)) enize dover mine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA aciding 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/dsmamain.html".

Sincerely yours,
Steven Litman

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): Not yet assigned

SYNCHRON® Systems Methadone Reagent Device Name:

Indications for Use:

21 CFR 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carl Benam, L. Alfred Montgomery

(Division Sign-Off) O
Division of Clinical Laboratory Devices
510(k) Number K973069

Prescription Use
(per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96

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).