The SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.

Device Description

The SYNCHRON® Systems DAT Opiates Reagent is in a ready-to-use liquid format and packaged into bar coded cartridges that are placed directly onto the SYNCHRON Systems.

AI/ML Overview

The provided text describes a qualitative diagnostic reagent, the SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent, not a medical "device" in the sense of a machine or AI system typically requiring extensive performance studies with complex acceptance criteria. Therefore, many of the requested categories for a medical device's performance study, especially those related to AI and human reader effectiveness, are not applicable to this submission.

Here's an analysis based on the provided text, focusing on what is relevant for this type of diagnostic reagent.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of qualitative diagnostic assay, "acceptance criteria" are typically related to its intended use and demonstrating substantial equivalence to a predicate device. The primary performance characteristic highlighted is stability.

Acceptance Criteria (Implied/General for IVD Reagents)	Reported Device Performance
Substantial Equivalence to Predicate	Supported by Premarket Notification data
Stability	12 months (validated by stress stability studies)
Qualitative Determination of Opiates	Intended for use in qualitative determination at 2000 ng/mL

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

The document does not explicitly state the sample size used for the performance data or the data provenance (e.g., country of origin, retrospective/prospective). It generally states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to Opiate Test Systems already in commercial distribution."

For in vitro diagnostic reagents, performance studies typically involve testing a range of known positive and negative samples, as well as samples with concentrations around the cutoff. However, the specific details are not provided in this summary.

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

This concept is not applicable to this type of in vitro diagnostic reagent. The "ground truth" for chemical assays like this is established by reference methods, known concentrations of analytes, or other validated diagnostic tests, not by expert consensus on image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of in vitro diagnostic reagent. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers or interpreters, which is not relevant here.

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

This concept is not applicable. This is a laboratory reagent for chemical analysis, not an AI-powered diagnostic imaging or decision support system that would involve human readers.

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

This concept is not applicable. This is a chemical reagent, not an algorithm. The "performance" is the reagent's ability to react with opiates in a urine sample to produce a qualitative result (positive/negative) when analyzed by the SYNCHRON System. The system itself is "standalone" in its analytical process, but it's not an algorithm in the sense of AI.

7. The Type of Ground Truth Used

The "ground truth" for a chemical assay like this would typically be established by:

Known concentrations: Using urine samples spiked with known amounts of opiates.
Reference analytical methods: Such as Gas Chromatography-Mass Spectrometry (GC-MS), which is considered a gold standard for drug identification and quantification.
Comparison to a legally marketed predicate device: As this submission emphasizes, substantial equivalence to the Emit® II Opiates 300/2000 Assay is crucial. The predicate's performance would serve as a comparative ground truth.

The document states: "The SYNCHRON Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL". This implies that the ground truth is based on the concentration of opiates in urine relative to the 2000 ng/mL cutoff, determined by reliable analytical methods and calibrated using reference calibrators.

8. The Sample Size for the Training Set

This concept is not applicable as this is not an AI or machine learning device that requires a "training set." The development of the reagent involves chemical formulation and optimization, not data-driven model training.

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

This concept is not applicable for the reasons stated above.

Summary

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K9841152

JAN 29 1999

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Summary of Safety & Effectiveness SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent

1.0 Submitted By:

Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123

2.0 Date Submitted:

November 17, 1998

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Opiates 2000 ng Reagent

3.2 Classification Name

Opiate Test System (21 CFR §862.3650)

4.0 Predicate Device(s):

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsOpiate 2000 ng Reagent	Emit® II Opiates300/2000 Assay	Behring Diagnostics,Inc.*	K971596

*Behring Diagnostics, Inc. (formerly SYVA), Cupertino, CA

5.0 Description:

The SYNCHRON® Systems DAT Opiates Reagent is in a ready-to-use liquid format and packaged into bar coded cartridges that are placed directly onto the SYNCHRON Systems.

Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Opiates 2000 ng Reagent Summary of Safety & Effectiveness

5.0 Intended Use:

The SYNCHRON Systems Opiates 2000 ng (OP2) Reagent, in conjunction with the SYNCHRON System Drugs of Abuse (DAT) Urine Calibrators, is intended for use in the qualitative determination of Opiates in human urine at a cutoff value of 2000 ng/mL, on SYNCHRON Systems.

7.0 Comparison to Predicate(s):

Same intended use and chemical reaction as the predicate. The SYNCHRON Opiates 2000 ng Reagent uses mouse antibodies and the Emit II Opiates Reagent uses goat antibodies.

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to Opiate Test Systems already in commercial distribution. Stress stability studies of the Opiates 2000 ng Reagent support the Beckman stability claim of 12 months.

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 regulation 21 CFR 807.92.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 29 1999

Lucinda Stockert Staff Regulatory Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea, CA 92622-8000

Re: K984152

Trade Name: SYNCHRON® Systems Opiates 2000 ng (OP2) Reagent Regulatory Class: II Product Code: DJG Dated: January 14, 1999 Received: January 19, 1999

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 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 Regulations. 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 regulatory 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 Radiological Health

Enclosure

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page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): Not yet assigned

Device Name: SYNCHRON® Systems Opiates 2000 ng Reagent

Indications for Use:

21 CFR 862.3650 Opiates Test System

(a) Identification. An Opiate test system is a device intended to measure any of the addictive narcotic pain relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine heroin. codeine, nalorphine, and meperedine. alucoronide. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and monitoring the levels of opiate administration to ensure appropriate therapy.

(b) Classification. Class II.
	Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number:	K984152

	Dean Cooge
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	x 984152

(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

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).