WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL

K121166 · Guangzhou Wondfo Biotech Co., Ltd. · DIO · May 8, 2012 · Clinical Toxicology

Device Facts

Record IDK121166
Device NameWONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Product CodeDIO · Clinical Toxicology
Decision DateMay 8, 2012
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 862.3250
Device ClassClass 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 Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine at the cutoff concentrations of: Cocaine /COC 300 ng/mL; Methamphetamine (MET) 1000 ng/mL; Methylenedioxymethamphetamine (MDMA) 500 ng/mL; Morphine (MOP) 300 ng/mL; Methadone (MTD) 300 ng/mL; Morphine 2000 (OPI) 2000 ng/mL; Phencyclidine (PCP) 25 ng/mL; Notriptyline (TCA) 1000 ng/mL. 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. 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 for qualitative detection of drugs of abuse in human urine; competitive binding principle. Input: human urine sample. Output: visual colored lines on test strip; absence of line in test region indicates positive result (drug concentration above cutoff); presence of line indicates negative result or concentration below cutoff; control line confirms test validity. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary results requiring confirmation via GC/MS. Assists in clinical decision-making regarding drug screening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding format. Multi-drug test cup or panel configuration (2-8 analytes). Visual readout via colored lines. Standalone device; no energy source required. No software or electronic components.

Indications for Use

Indicated for the qualitative detection of drugs of abuse in human urine samples.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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

Related Devices

Submission Summary (Full Text)

{0} SPECIAL 510(k): Device Modification OIVD Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER k121166 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 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 immuchromatographic 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. Reagnets and antibodies on the device are similar to previously cleared devices. Cups and panels are combined to include up to two to eight 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.
Innolitics

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