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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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K_051307

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k023048
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The modification involves a change to the reagent antibody. The reagent antibody has been modified for revalidation of drug cross-reactivity.

4. Comparison Information similarities to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.