SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT

K043556 · Beckman Coulter, Inc. · JXM · Mar 28, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043556
• Device Name: SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Mar 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

This device is used in the diagnosis and treatment of benzodiazepine use or overdose. 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 of 200 ng/mL (oxazepam). 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

The BNZG reagent is a liquid stable reagent used with SYNCHRON® clinical chemistry systems for the qualitative screening of benzodiazepines in human urine. The assay utilizes an immunological reaction involving a specific antibody and a glucuronidase enzyme to detect the presence of benzodiazepine analytes at a 200 ng/mL cutoff. The system processes urine samples and produces a qualitative result; preliminary positive results must be confirmed by non-immunological methods such as GC/MS. The device is intended for use by laboratory professionals in clinical settings to assist in the diagnosis and treatment of benzodiazepine use. Healthcare providers use the output to guide clinical decision-making regarding patient therapy and drug use management.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A (n=80 per system); within-run imprecision ≤0.8%, total imprecision ≤1.0%. Method comparison study (n=158) against GC/MS showed 92% overall agreement. Performance around 200 ng/mL cutoff verified. Interference testing performed for common drugs and urine matrices per NCCLS EP7-A.

Technological Characteristics

Qualitative immunoassay; competitive binding principle. Reagents: polyclonal goat anti-benzodiazepine antibodies, G6PDH-labeled benzodiazepine analog, β-glucuronidase. Detection: spectrophotometric absorbance at 340 nm. Platform: Beckman Coulter Synchron LX and CX systems. Connectivity: standalone system integration. Sterilization: not applicable (reagent).

Indications for Use

Indicated for the qualitative screening of benzodiazepines in human urine to aid in the diagnosis and treatment of benzodiazepine use. Intended for use in clinical settings. Preliminary positive results require confirmation by non-immunological methods (e.g., GC/MS).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• SYNCHRON Systems BENZ Reagent (k023048 and k944076)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

#### 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 | Docket<br>Number |
|----------------------------------|----------------------------------|--------------------------|------------------|
| SYNCHRON Systems<br>BNZG Reagent | SYNCHRON Systems<br>BENZ Reagent | Beckman Coulter,<br>Inc. | K023048 |

#### 5.0 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.

#### 6.0 Intended Use:

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).

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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 Use<br>Liquid stable reagent<br>Stability<br>Calibrators<br>Controls | Same as BENZ |
| | Differences | |
| BNZG Reagent | Cross reactivity | Different due to new antibody and<br>glucuronidase enzyme |
| | Reagent volume | 260 µL for BNZG due to enzyme<br>250 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 | Overall<br>Agreement | 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 | Overall<br>Agreement | 92% |
| | TOTAL | 103 | 55 | 158 | | |

# SYNCHRON CX System BNZG Reagent Imprecision Results

| Sample | Mean<br>Rate<br>(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 | Mean<br>Rate<br>(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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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 [phone]. 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 [phone] or [phone] 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