TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC

K032057 · Branan Medical Corp. · DIO · Aug 21, 2003 · Clinical Toxicology

Device Facts

• Record ID: K032057
• Device Name: TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
• Applicant: Branan Medical Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations: AMP (d-Amphetamine) 1000 ng/ml; COC (Benzoylecgonine) 300 ng/ml; MET500 (d-Methamphetamine) 500 ng/ml; OPI2000 (Morphine) 2000 ng/ml; OPI300 (Morphine) 300 ng/ml; PCP (Phencyclidine) 25 ng/ml; THC (11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid) 50 ng/ml. The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cut-off concentration indicated. The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-of-abused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Device Story

ToxCup™ Drug Screen Cup; in vitro diagnostic device for professional use. Input: human urine sample. Principle: chromatographic immunoassays. Output: visual, qualitative results for presence of drugs of abuse (AMP, COC, MET, OPI, PCP, THC). Used in clinical settings by healthcare professionals. Provides rapid screening to assist in identifying drug presence; results are qualitative and intended for professional use only.

Clinical Evidence

No clinical data provided; device relies on bench testing of chromatographic immunoassay performance at specified cutoff concentrations.

Technological Characteristics

In vitro diagnostic test strips; cup-based form factor; visual qualitative detection; chemical assay principle.

Indications for Use

Indicated for use as a diagnostic test for the qualitative detection of drugs of abuse in human urine.

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).

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 K032057

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II devices requiring 510(k). The following items are present and acceptable:

1. The names and 510(k) numbers of the SUBMITTER'S previously cleared devices.
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 MODIFICATIONS, including user's manual in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The modifications were as follows:
- Change in the dimension of the test strips
- Incorporation of the test strips into a cup device
- Change in the package insert to indicate that the test results are stable up to 1 hour and to include accuracy and precision results from Point of Care (POC) sites

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

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method 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 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) Statement and the Indications for Use Enclosure.

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 modifications 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 devices.