Opiate 300 ng (OP) Reagent, in conjunction with the SYNCHRON® System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems.

The Opiate assay provides a rapid screening procedure for determining the presence of opiates in urine. This 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 chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.12

Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Description

The SYNCHRON Systems Opiate (OP) reagent is designed for optimal SYNCHRON performance on on the CX (CX4/4CE/4A/4PRO, CX5/5CE/5A/5PRO. CX7/7RTS/7Δ/7PRO. CX9ALX/9PRO) and LX (LX20/PRO/LXi) Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.

AI/ML Overview

Here's an analysis of the provided text regarding the SYNCHRON® Systems Opiate Reagent, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary for a medical device. These summaries typically provide a high-level overview of performance data and substantial equivalence to a predicate device. They often do not contain detailed statistical analyses, precise sample sizes for specific tests, or comprehensive descriptions of ground truth establishment to the extent often found in a full scientific publication or detailed study report. The information below is extracted directly from the provided document, and any missing details are due to their absence in the given text.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for performance metrics (e.g., specific sensitivity, specificity, accuracy targets). Instead, it makes a general statement about equivalency. The primary performance claim is that the device is "substantially equivalent" to a legally marketed predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Not Explicitly Stated as Numerical Targets)	Reported Device Performance
Overall Performance	Substantial equivalence to the predicate device (SYNCHRON Systems Opiate Reagent, K944606)	"Performance data from validation testing supports equivalency."

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but the device is intended for "human urine," implying human samples were used. It's common for such tests to use both spiked (controlled concentration) and patient samples, but this is not detailed here. The submission is from the US, for a US market, but the origin of the data is not stated. There is no indication whether the data is retrospective or prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified. The document states that a positive result should be confirmed by methods like TLC, GC, or GC/MS (with GC/MS being preferred). This implies that these confirmatory methods establish the "ground truth" for ambiguous or positive results, rather than human experts directly interpreting results from the device under review.
Adjudication Method for the Test Set:
- Not applicable as the ground truth appears to be established by analytical confirmatory tests (TLC, GC, GC/MS) rather than expert review. If multiple confirmatory tests were used, a method for reconciling discrepancies (e.g., 2+1, 3+1) might have been employed, but this is not mentioned.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is an in-vitro diagnostic (IVD) device, specifically a reagent for an automated system. MRMC studies are typically performed for imaging or qualitative diagnostic tests that rely on human interpretation. This device's performance is assessed analytically.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this device inherently functions as a standalone algorithm (a reagent on an automated system). Its purpose is to provide a "preliminary analytical result." Human involvement comes after the device provides its result, in the form of clinical consideration and confirmatory testing. The "performance data from validation testing" would be of the algorithm/reagent-system combination itself.
The Type of Ground Truth Used:
- The document implies that the ground truth for determining the actual presence and concentration of opiates is established by "generally accepted non-immunological methods, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS)." GC/MS is explicitly stated as the "preferred confirmatory method." This falls under analytical/confirmatory testing.
The Sample Size for the Training Set:
- Not specified. The document describes a modification to an existing device (K944606), where "the SYNCHRON Systems Opiate reagent antibody has been modified for drug cross-reactivity." This implies the "training" (development/optimization) involved adjusting the antibody to achieve desired cross-reactivity profiles. The sample size of assays performed during this development phase is not disclosed.
How the Ground Truth for the Training Set Was Established:
- Not explicitly described. For the modification of the antibody's cross-reactivity, ground truth would have been established by preparing samples with known concentrations of various opiates and related compounds (both target and interfering substances). These samples would then be analyzed using reference methods (like GC/MS) to confirm their composition and concentration, allowing researchers to optimize the antibody's performance against these known standards.

Summary

{0}------------------------------------------------

K031002

APR 2 9 2003

510(k) SUMMARY

1.0 Submitted Bv:

Kim Walker Senior Requlatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123

Date Submitted 2.0

March 25, 2003

3.0 Device Name(s):

3.1 Proprietary Names SYNCHRON Systems Opiate Reagent
3.2 Classification Names Opiate test system. [862.3650]

4.0 Legally Marketed Device

The SYNCHRON Systems Opiate Reagent claims substantial equivalence to the SYNCHRON Systems Opiate Reagent currently in commercial distribution. (FDA 510(k) Number K944606)

5.0 Device Description

{1}------------------------------------------------

6.0 Intended Use

Opiate 300 nq (OP) Reagent, in conjunction with the SYNCHRON® System OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine, at a cutoff value of 300 ng/mL (morphine), on SYNCHRON Systems.

Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)

The SYNCHRON Systems Opiate reagent antibody has been modified for drug cross-reactivity.

8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy line.

APR 2 9 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kim Walker Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-104, Box 8000 Brea, CA 92822-8000

Re: K031002

Trade/Device Name: SYNCHRON® Systems Opiate Reagent Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: March 25, 2003 Received: March 31, 2003

Dear Ms. Walker:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

page 1 of 1

510(k) Number (if known):

SYNCHRON® Systems Opiate Reagent Device Name:

Indications for Use:

Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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

i
OR
Prescription Use
(per 21 CFR 801.109)
Over-the-Counter Use
Optional Format 1-2-96

Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K031002

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Opiate Reagent File: OP_s510(k).doc 03/03

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).