WONDOFO MULTI-DRUG URINE TEST CUP / PANEL

K130665 · Guangzhou Wondfo Biotech Co., Ltd. · DJG · Apr 9, 2013 · Clinical Toxicology

Device Facts

• Record ID: K130665
• Device Name: WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Apr 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• 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 Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine 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 method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test will yield preliminary positive results when prescription drugs Buprenorphine, 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

Lateral flow immunochromatographic assay; competitive binding principle. Input: human urine sample. Device consists of test strips detecting specific drug analytes. Positive result: no colored line in test region; negative result: colored line appears. Control line always appears. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary qualitative screening for drugs of abuse. Results require confirmation via GC/MS or LC/MS. Assists clinical decision-making by identifying potential drug presence; requires professional judgment for interpretation, especially regarding prescription medications.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding. Form factors: test cup and dip card. Multi-analyte configuration (2-12 drugs). Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of cocaine and methamphetamine in human urine. Intended for use by healthcare professionals and in clinical settings for the detection of drug presence.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

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

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k130665

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. K112071; Wondfo Cocaine Urine Test, 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 analysis.

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.