Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

K153050 · Co-Innovation Biotech Co., Ltd. · DJG · Apr 26, 2016 · Clinical Toxicology

Device Facts

• Record ID: K153050
• Device Name: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
• Applicant: Co-Innovation Biotech Co., Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Apr 26, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The One Step Single/Multi-drug Test Cup and Dipcard is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at specified cutoff levels. The device is intended for professional use only.

Device Story

Lateral flow chromatographic immunoassay; detects drugs/metabolites in human urine; qualitative visual readout. Modification combines five analytes from k140748 with eleven analytes from k142800 into single test cup/dipcard format. Used in professional clinical settings; provides rapid screening results for healthcare providers to assist in clinical decision-making regarding substance use.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence established via design control activities, risk analysis, and verification/validation of the combined analyte panel.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Cup and Test Dipcard. Analyte-specific test strips with identical chemical formulations. No energy source required. Standalone device. Storage: 4-30°C.

Indications for Use

Indicated for qualitative detection of drugs and drug metabolites in human urine for prescription and over-the-counter use. Target population includes individuals requiring drug screening. Analytes: Marijuana, Cocaine, Amphetamine, Methamphetamine, Morphine (2000/300), Barbiturates, Benzodiazepines, MDMA, Methadone, Oxycodone, Phencyclidine, Buprenorphine, EDDP, Propoxyphene, TCA.

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

• One Step Single/Multi-drug Test Cup and Dipcard (k140748)
• Rapid Single/Multi-drug Test Cup and Dipcard (k142800)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER

k153050

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.

One Step Single/Multi-drug Test Cup and Dipcard – k140748
Rapid Single/Multi-drug Test Cup and Dipcard – k142800

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 five analytes cleared in k140748 (Buprenorphine, EDDP (2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine), Morphine, Propoxyphene, and Tricyclic Antidepressants) with the eleven analytes cleared in k142800 (Amphetamine, Methamphetamine, Cocaine, Morphine, Cannabinoid, Barbiturates, Benzodiazepines, Methadone, Methylenedioxymethamphetamine, Oxycodone, and Phencyclidine).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analyte 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.