WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;

K122904 · Guangzhou Wondfo Biotech Co., Ltd. · DKZ · Nov 15, 2012 · Clinical Toxicology

Device Facts

• Record ID: K122904
• Device Name: WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Nov 15, 2012
• 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 of Methamphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Amphetamine, Phencyclidine, Notriptyline and Methadone, Methylenedioxymethamphetamine, Morphine, Oxycodone in human urine at the cutoff concentrations of: [Table of cut-off levels]. 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 method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drugs Notriptyline, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Story

Wondfo Multi-Drug Urine Test Cup and Panel are lateral flow immunochromatographic assays; detect drugs of abuse in human urine. Principle: competitive binding; antigen-antibody interaction. Input: human urine sample. Output: visual colored lines on test strips; absence of line in test region indicates positive result (drug concentration above cutoff); presence of line indicates negative result. Control line always appears. Used in clinical or home settings; operated by clinicians or patients. Provides preliminary screening results; requires confirmatory testing via GC/MS or LC/MS for clinical decision-making. Benefits: rapid, simultaneous screening for multiple substances.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures; results met predetermined acceptance criteria.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: test cup and dip card. Analyte detection via antigen-antibody interaction. No electronic components, energy source, or software algorithms.

Indications for Use

Indicated for qualitative, simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, MDMA, Morphine, Methadone, Phencyclidine, Notriptyline, and Oxycodone in human urine. For prescription and OTC use. Preliminary results only; requires confirmatory testing (GC/MS or LC/MS).

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

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K122904

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

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 incorporating previously cleared cup and panel immunochromatographic assays into the device.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and detection technologies. Reagents and antibodies on the device are similar to previously cleared devices. Cups and panels are combined to include test strips from two to twelve drugs of abuse tests.

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.