PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X

K043167 · Phamatech, Inc. · JXM · Dec 29, 2004 · Clinical Toxicology

Device Facts

• Record ID: K043167
• Device Name: PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
• Applicant: Phamatech, Inc.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Dec 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Indications for Use

The QuickScreen™ Benzodiazepines Test is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine. The cutoff concentration for this test is 200 ng/ml. This assay is intended for professional use.

Device Story

QuickScreen™ Benzodiazepines Test is a rapid, qualitative, one-step immunoassay for urine drug screening. Device utilizes visual color sandwich immunochemical technology to detect benzodiazepines at a 200 ng/ml cutoff. Professional users perform the test in clinical settings. The assay relies on specific antibody-target analyte-antibody complexes to produce a visual result. Healthcare providers use the qualitative output to aid in the diagnosis and treatment of drug abuse. The device provides a rapid screening tool for clinical decision-making regarding patient drug use status.

Clinical Evidence

Clinical performance evaluated via clinical sample correlation study and blind labeled spiked study. Results showed 97.9% correlation with predicate devices for the qualitative detection of benzodiazepines in urine.

Technological Characteristics

Rapid, qualitative, one-step visual color sandwich immunoassay. Designed for professional use. Detects benzodiazepines at 200 ng/ml cutoff. No electronic components, software, or external energy sources required.

Indications for Use

Indicated for professional use in the qualitative detection of benzodiazepines (and other drugs of abuse including amphetamine, cocaine, methamphetamine, opiates, PCP, barbiturates, methadone, and THC depending on model) in human urine to assist in the diagnosis and treatment of drug abuse.

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).

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K043167

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.)
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.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, 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 manufacturer has added samples to the method comparison section of the performance claim.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and laboratory performance.

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 or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.