Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL, on SYNCHRON Systems.

The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines 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.

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

Device Description

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

AI/ML Overview

The provided text (K023048) is a 510(k) summary for the SYNCHRON Systems Benzodiazepine Reagent. It outlines the device's intended use, its relationship to a predicate device, and generally states that "Performance data from validation testing supports equivalency."

However, the provided document does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria in a quantitative manner. It's a regulatory summary, not a technical performance report. Therefore, I cannot fully complete all sections of your request based solely on the provided text.

Here's what I can extract and what is missing:

Acceptance Criteria and Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL.	"Performance data from validation testing supports equivalency." (No specific metrics like sensitivity, specificity, accuracy, or concordance are provided in this summary.)
Equivalent performance to the predicate device (SYNCHRON Systems Benzodiazepine Reagent K944076).	"Performance data from validation testing supports equivalency." (No detailed comparison results are given.)
The assay provides a rapid screening procedure.	Implied by the nature of the device, but no quantitative measure of "rapid" is provided.
Preliminary analytical result, requiring confirmation by non-immunological methods (TLC, GC, GC/MS).	The device description specifies this as part of its intended use, indicating it meets this functional characteristic.
Modified antibody for drug cross-reactivity provides equivalent or improved performance.	The summary states "The SYNCHRON Systems Benzodiazepine reagent antibody has been modified for drug cross-reactivity," and performance supports equivalency. However, no specific cross-reactivity data or comparison is provided.

Study Details (Based on available information in the 510(k) summary)

Sample size used for the test set and the data provenance:
This information is not provided in the 510(k) summary. The document only states "Performance data from validation testing supports equivalency" without detailing the nature, size, or origin of the samples used in that testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The device is an in vitro diagnostic device that measures a chemical compound. Ground truth for such devices is typically established through a reference method (like GC/MS), not usually by expert human consensus in the same way an image analysis algorithm might be.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. Adjudication by multiple experts is typically used for subjective assessments (e.g., in medical imaging). For a quantitative chemical assay, the "ground truth" is typically established by an independent, highly accurate reference method (e.g., GC/MS), rather than human adjudication.
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 is not applicable. This device is a reagent for an automated in vitro diagnostic system, not an AI or imaging device designed to assist human readers in interpretation. There are no "human readers" in the context of this device's primary function; it provides a direct qualitative result.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, implicitly. As an in vitro diagnostic reagent run on an automated system (SYNCHRON Systems), its performance is inherently "standalone" in terms of generating the qualitative result. The "human-in-the-loop" aspect comes after the preliminary result, where a clinician applies judgment and, if positive, orders confirmatory tests. The performance data would relate to the accuracy of the reagent/system itself. However, the details of such a standalone study (e.g., sensitivity, specificity, accuracy against a gold standard) are not provided in this summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the preferred confirmatory method is stated as GC/MS (gas chromatography/mass spectrometry). This would be the "gold standard" or "ground truth" against which the device's performance would be compared.
The sample size for the training set:
This information is not provided. The summary mentions the antibody was "modified," implying development and potentially "training" or optimization, but no details on training data size are given.
How the ground truth for the training set was established:
This information is not provided. However, it would logically be established using a similar approach to the test set ground truth, most likely using a reference method like GC/MS.

In summary: The 510(k) summary provides the regulatory context and intended use but lacks the detailed performance metrics and study design specifics you've requested. This level of detail is typically found in the full 510(k) submission document or supporting technical reports, not usually in the summary itself.

Summary

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K023048

NOV 7 2002

510(k) SUMMARY

1.0 Submitted By:

Annette Hellie Requlatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123

2.0 Date Submitted

September 12, 2002

3.0 Device Name(s):

3.1 Proprietary Names SYNCHRON Systems Benzodiazepine Reagent
3.2 Classification Names Benzodiazepine test system. [862.3170]

4.0 Legally Marketed Device

The SYNCHRON Systems Benzodiazepine Reagent claims substantial equivalence to the SYNCHRON Systems Benzodiazepine Reagent currently in commercial distribution. (FDA 510(k) Number K944076)

5.0 Device Description

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6.0 Intended Use

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

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

8.0 Summary of Performance Data

Performance data from validation testing supports equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of three overlapping human figures.

NOV 7 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 P.O. Box 8000 Brea. CA 92822-8000

K023048

Re:

Trade/Device Name: Synchron® Systems Benzodiazepine Reagent Regulation Number: 21 CFR 862.3170 Regulation Name: Antimony test system Regulatory Class: Class II Product Code: JXM Dated: October 24, 2002 Received: October 24, 2002

Dear Ms. Hellie:

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. Iisting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 vour 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other veneral 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/cdrb/dsmaldsmamain.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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page 1 of 1

03304 510(k) Number (if known):

SYNCHRON® Systems Benzodiazepine Reagent Device Name:

Indications for Use:

The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines 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 laver chromatography (TLC), gas chromatography (GC), or gas chromatography/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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (per 21 CFR 801.109)

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

Alan Cooper

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

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Benzodiazepine Reagent File: BENZ s510k.doc 9/02

Regulation Number and Section

§ 862.3170 Benzodiazepine test system.

(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).