SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT

K051307 · Beckman Coulter, Inc. · JXM · Jun 13, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051307
• Device Name: SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

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 (oxazepam), 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 Story

Reagent kit for qualitative screening of benzodiazepines in human urine; used on Beckman Coulter SYNCHRON clinical chemistry analyzers. Input: human urine sample; reagent antibody reacts with benzodiazepines. Output: preliminary qualitative result indicating presence or absence of drug above 200 ng/mL cutoff. Operated by laboratory personnel in clinical settings. Results used as rapid screening tool; positive findings require confirmation via GC/MS or similar non-immunological methods. Clinical decision-making relies on professional judgment following preliminary screening. Benefits include rapid identification of potential benzodiazepine presence to guide further diagnostic or clinical action.

Clinical Evidence

Bench testing only; verification and validation activities performed per risk analysis to confirm modification impact.

Technological Characteristics

Reagent antibody modification; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the qualitative screening of benzodiazepines in human urine at a 200 ng/mL (oxazepam) cutoff. Intended for use on SYNCHRON Systems as a preliminary analytical test requiring confirmation by non-immunological methods.

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 Benzodiazepine Reagent (K023048)

Submission Summary (Full Text)

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# JUN 1 3 2005

## 510(k) SUMMARY

051307

#### 1.0 Submitted By:

Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: [phone] FAX: [phone]

#### Date Submitted 2.0

May 18, 2005

#### 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 K023048)

#### 5.0 Device Description

The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4A/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO, LX20/PRO, and UniCel DxC 600/800 Systems. The reagent kit contains one 250-test cartridge that is packaged separately from the associated calibrators.

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K051307
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#### 6.0 Intended Use

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 (oxazepam), 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.

### 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

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the central image.

JUN 1 3 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. W-110 Brea, CA 92822-8000

k051307 Re: -Trade/Device Name: SYNCHRON® Systems Benzodiazepine Reagent Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: May 18, 2005 Received: May 19, 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,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

SYNCHRON® Systems Benzodiazepine Reagent Device Name:

Indications for Use:

Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON ® Systems Denzoulazepine (DAT) Urine Calibrators, is intended for the qualitative Drugs of Abuso Tooting (D. of human urine at a cutoff value of 200 ng/mL, (oxazepam) on SYNCHRON Systems.

The Benzodiazepine assay provides a rapid screening procedure for determining I he Bonzodiazepines adjazepines in urine. This test provides only a preliminary the probentive result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin laver gonomatography (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.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR -

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Bute a chule

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k051307

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Benzodiazepine Reagent File: BENZ 2005 s510k.doc, 5/05