Wondfo CR3 Keyless Split Sample Cup

K151478 · Guangzhou Wondfo Biotech Co., Ltd. · DJG · Jul 1, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151478
• Device Name: Wondfo CR3 Keyless Split Sample Cup
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jul 1, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The combination of the previously cleared drugs of abuse test devices (cleared in k140089, k141532, k142044, k142609, k143535, k150179, and k150602) into the candidate multi-test devices that can detect a combination of up to 13 drugs of abuse at the same time.

Device Story

Wondfo CR3 Keyless Split Sample Cup; lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Device uses competitive binding principle; mouse monoclonal anti-drug antibody-dye conjugates; fixed drug-protein conjugates; anti-mouse IgG polyclonal antibodies on test membranes. Urine sample absorbed via capillary action; mixes with antibody-dye conjugate. Analyte below cutoff: antibody-dye binds to immobilized drug-protein in Test Region (T); colored line indicates negative result. Analyte above cutoff: analyte binds antibody-dye; prevents binding to Test Region; no colored line indicates preliminary positive. Control line (C) confirms proper flow. Used in clinical or home settings; operated by clinicians or lay users. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS). Aids in identifying potential drug presence; clinical judgment required for interpretation.

Clinical Evidence

Bench testing only. Verification and validation activities performed based on risk analysis to confirm performance of combined test strips within the multi-test cup format.

Technological Characteristics

Multi-test cup format; lateral flow immunoassay technology; qualitative visual readout; integrated sample collection and testing; no electronic components or software.

Indications for Use

Indicated for the qualitative detection of up to 13 drugs of abuse in urine samples.

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 CR3 Keyless dual drug of abuse tests (k141532, k140089, k142044, k142609, k143535, k150179, k150602)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K151478

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.)

k140089, CR3 Keyless Split Sample Cup (OPI-BZO);
k141532, CR3 Keyless Split Sample Cup Amphetamine-Cocaine;
k142044, CR3 Keyless Split Sample Cup Phencyclidine – Methylenedioxymethamphetamine;
k142609, CR3 Keyless Split Sample Cup Nortriptyline – Buprenorphine
k143535, CR3 Keyless Split Sample Cup Secobarbital-Methadone
k150179, CR3 Keyless Split Sample Cup Oxycodone – Cannabinoids
k150602, CR3 Keyless Split Sample Cup Morphine – Methamphetamine

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 drugs of abuse test devices (cleared in k140089, k141532, k142044, k142609, k143535, k150179, and k150602) into the candidate multi-test devices that can detect a combination of up to 13 drugs 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, and cutoffs.

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

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.