AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)

K113501 · Ameditech, Inc. · DIO · Dec 5, 2011 · Clinical Toxicology

Device Facts

• Record ID: K113501
• Device Name: AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
• Applicant: Ameditech, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Dec 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

The CHECKCUP™ Multi-Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations: [Table of 17 drugs/metabolites with cutoffs]. The CHECKCUP™ Multi-Drug Test consists of two test formats: flat cup and round cup. The configurations of the CHECKCUP™ Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP™ is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.

Device Story

Lateral flow immunoassay for qualitative detection of drugs/metabolites in human urine. Device consists of round or flat cup containing up to 17 test strips. Urine sample added to cup; results read visually by professional user. Presence of line in test region indicates negative; absence indicates positive. Control line confirms proper test performance. Results available in 1-10 minutes. Used in clinical/professional settings for preliminary screening; requires GC/MS or LC/MS confirmation. Benefits include rapid, multi-drug screening capability.

Clinical Evidence

No clinical studies were conducted. Performance characteristics were established via analytical performance verification and validation testing (bench testing only), leveraging data from the predicate device and K113046.

Technological Characteristics

Lateral flow immunoassay; visual readout. Consists of round or flat plastic cup housing multiple 1-drug or 2-drug test strips. No electronic components, energy source, or software. Connectivity: None. Sterilization: Not specified.

Indications for Use

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

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

• Ameditech DrugSmart Cup (K053175)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K113501

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.) Ameditech DrugSmart Cup k053175.
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: 1. the addition of four previously cleared test strips into the device. 2. a modification to the round cup and holder to have a flat cup on one side which will house a flat test strip holder.

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

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.