Chemtrue Multi-Panel DOA DIP Card Tests

K142580 · Chemtron Biotech, Inc. · DKZ · Dec 1, 2014 · Clinical Toxicology

Device Facts

• Record ID: K142580
• Device Name: Chemtrue Multi-Panel DOA DIP Card Tests
• Applicant: Chemtron Biotech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Dec 1, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The combination of the previously cleared drugs of abuse test devices into the candidate multi-test device that can detect a combination of up to 11 drugs of abuse at the same time.

Device Story

Multi-panel drug screen dip card/cassette; detects up to 11 drugs of abuse simultaneously in human urine; lateral flow immunoassay technology; provides qualitative results; intended for professional use; aids in identifying drug presence; results interpreted visually by clinician.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance of combined multi-test format against individual cleared predicate tests.

Technological Characteristics

Lateral flow immunoassay; dip card/cassette form factor; qualitative detection; multi-panel configuration for up to 11 analytes.

Indications for Use

Indicated for the qualitative detection of up to 11 drugs of abuse in human urine specimens.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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

• Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k102203)
• Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k111322)
• Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k121339)
• Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests (k123080)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Summary (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K142580

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.)

Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests k102203, k121339, k111322 and k123080

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, 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.

4. This change was for:

The combination of the previously cleared drugs of abuse test devices into the candidate multi-test device that can detect a combination of up to 11 drugs of abuse at the same time.

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

6. 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

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.