BNZG reagent, when used in conjunction with SYNCHRON® System(s) and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine (BNZG) in human urine at a cutoff value of 200 ng/mL (oxazepam).

Device Description

The BNZG assay provides a rapid screening procedure for determining the presence of the analyte in urine. This test provides only a preliminary analytical result, a positive result by these assays 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the SYNCHRON® Systems BNZG Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state 'acceptance criteria' in a formal table with predefined targets. However, the study aims to demonstrate substantial equivalence to a predicate device, and the concordance summary provides the key performance metrics. Based on common practice for this type of device, acceptable performance would typically involve high sensitivity, specificity, and overall agreement with a confirmatory method, as well as good imprecision.

Here's a table based on the provided results, with implied acceptance based on the successful clearance of the device:

Metric	Acceptance Criteria (Implied)	Reported Device Performance (SYNCHRON® Systems BNZG Reagent)
Concordance Study
Sensitivity	High agreement with GC/MS (e.g., >90%)	98% (for both SYNCHRON CX and LX systems)
Specificity	High agreement with GC/MS (e.g., >80%)	84% (for both SYNCHRON CX and LX systems)
Overall Agreement	High agreement with GC/MS (e.g., >90%)	92% (for both SYNCHRON CX and LX systems)
Imprecision Study		(Representative values shown)
Within-Run %CV	Low variability (e.g., < 2%)	0.5% - 1.0%
Total %CV	Low variability (e.g., < 2%)	0.7% - 1.0%

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

Sample Size: 158 urine samples were used for the concordance study (103 positive, 55 negative).
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only presents the summary of "Performance Data."

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

Number of Experts: Not applicable. The ground truth was established by a laboratory method (GC/MS), not by human expert opinion.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no need for adjudication as the ground truth was established by a single, preferred confirmatory method (GC/MS).

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

No, an MRMC comparative effectiveness study was not done. This device is a diagnostic reagent, not an AI-powered image analysis tool or a system designed for human interpretation. Its performance is measured directly against a reference method.

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

Yes, a standalone study was done. The performance data (sensitivity, specificity, overall agreement, imprecision) presented for the SYNCHRON® Systems BNZG Reagent are based solely on the device's analytical capabilities without human-in-the-loop performance influencing the primary measurements. The output is a qualitative determination (positive/negative), which is then compared to the GC/MS result directly.

7. The Type of Ground Truth Used

Ground Truth Type: Confirmatory laboratory method, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states, "GC/MS is the preferred confirmatory method."

8. The Sample Size for the Training Set

Not reported. The document focuses on the performance data of the reagent and does not provide information about a "training set," which is typically associated with machine learning or AI models. This is a traditional chemical assay, not an AI-driven device.

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

Not applicable. As no training set is mentioned or implied for this type of chemical reagent, the method for establishing its ground truth is not relevant here. The 'training' of such a device is typically through chemical formulation and optimization, not data-driven machine learning.

Summary

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K043556

MAR 2 8 2005

510(k) Summary SYNCHRON® Systems BNZG Reagent

1.0 Submitted By:

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

2.0 Date Submitted:

December 22, 2004

3.0 Device Name(s):

Proprietary Names 3.1

SYNCHRON® Systems Benzodiazepines (BNZG) Reagent

3.2 Classification Name

Benzodiazepine test system [21 CFR § 862.3170]

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
SYNCHRON SystemsBNZG Reagent	SYNCHRON SystemsBENZ Reagent	Beckman Coulter,Inc.	K023048

5.0 Description:

6.0 Intended Use:

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The BNZG assay provides a rapid screening procedure for determining the presence of The BNZS assay provides only a preliminary analytical result, a positive result by these assays should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas method such as thir layer onliners (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.

Clinical Significance:

Benzodiazepines are a class of central nervous system depressants that are used as Denzodiazepines are a class of contractiazepine compounds include chlordiazepoxide, Sedatives and Tryphotos. - The benz ditazepam. Measurements of benzodiazepines on ulazepan, ഗ്രാമായ്, nuralespann, al in the diagnosis and treatment of benzodiazepine use the orrestines of of of of are presence of benzodiazepines to ensure appropriate therapy.

Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

	Similarities
BNZG Reagent	Intended UseLiquid stable reagentStabilityCalibratorsControls	Same as BENZ
	Differences
BNZG Reagent	Cross reactivity	Different due to new antibody andglucuronidase enzyme
	Reagent volume	260 µL for BNZG due to enzyme250 µL for BENZ

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.

		SYNCHRON CX BNZG
		POS	NEG	TOTAL
GC/MS	POS	93	2	95	Sensitivity	98%
	NEG	10	53	63	Specificity	84%
	TOTAL	103	55	158	OverallAgreement	92%

BNZG Concordance Summary

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BNZG Concordance Summary SYNCHRON LX Systems

		SYNCHRON LX20 BNZG
		POS	NEG	TOTAL	Sensitivity	98%
GC/MS	POS	93	2	95	Specificity	84%
	NEG	10	53	63	OverallAgreement	92%
	TOTAL	103	55	158

SYNCHRON CX System BNZG Reagent Imprecision Results

Sample	MeanRate(mA/min)	S.D.	%C.V.	N
Within-Run Imprecision
Urine Control 1	408.95	2.129	0.5	80
Urine Control 2	447.26	3.431	0.8	80
Urine Pool	438.91	3.407	0.8	80
Total Imprecision
Urine Control 1	408.95	2.931	0.7	80
Urine Control 2	447.26	4.258	1.0	80
Urine Pool	438.91	3.883	0.9	80

SYNCHRON LX System BNZG Reagent Imprecision Results

Sample	MeanRate(mA/min)	S.D.	%C.V.	N
Within-Run Imprecision
Urine Control 1	439.00	3.276	0.8	80
Urine Control 2	480.04	4.631	1.0	80
Urine Pool	470.16	4.133	0.9	80
Total Imprecision
Urine Control 1	439.00	4.524	1.0	80
Urine Control 2	480.04	4.839	1.0	80
Urine Pool	470.16	4.905	1.0	80

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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized graphic of an abstract caduceus. The caduceus is depicted with three intertwined strands and a stylized wing at the top. The overall design is simple and monochromatic.

MAR 2 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K043556

Trade/Device Name: SYNCHRON® Systems Benzodiazepines (BNZG) Reagent Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepines test system Regulatory Class: Class II Product Code: JXM Dated: March 4, 2005 Received: March 15, 2005

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, 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).

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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 (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours.

Jean M. Cooper, MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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).