WONDFO MULTI-DRUG URINE TEST CUP, PANEL

K133968 · Guangzhou Wondfo Biotech Co., Ltd. · DKZ · Feb 25, 2014 · Clinical Toxicology

Device Facts

• Record ID: K133968
• Device Name: WONDFO MULTI-DRUG URINE TEST CUP, PANEL
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Feb 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Amphetamine, of Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of: [Table of cut-offs]. Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test may vield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Story

Device modification combines previously cleared single-analyte drug-of-abuse (DOA) tests into multi-test device; detects 2 to 13 drugs simultaneously in human urine. Input: urine sample; principle: lateral flow immunoassay; output: qualitative visual result (presence/absence of drug). Used at point-of-care sites by healthcare professionals. Output assists clinicians in assessing patient drug compliance.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm performance characteristics of the multi-test format compared to single-analyte predicates.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: test cup and test panel (dip card). Multi-analyte configuration (2-13 drugs). In vitro diagnostic use. No electronic components or software.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, MDMA, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone, Notriptyline) in human urine. Intended for OTC and prescription use. Not intended to distinguish between prescription use and abuse.

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

• Wondfo single DOA Tests (K112071)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k133968

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.) Wondfo Cocaine Urine Test and Wondfo Methamphetamine Urine Test (k112071).

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.

This change was for:

The combination of the previously cleared single DOA test devices that could detect only one drug at a time into the candidate multi-test device that can detect a combination of 2 to 13 drug of abuse at the same time.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, analytes and performance 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 or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).