← Product Code [DIO](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO) · K162395

# MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup (K162395)

_Mp Biomedicals, LLC · DIO · Jun 2, 2017 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO/K162395

## Device Facts

- **Applicant:** Mp Biomedicals, LLC
- **Product Code:** [DIO](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO.md)
- **Decision Date:** Jun 2, 2017
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.3250
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device. The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

## Device Story

In-vitro diagnostic test cups; detect drugs of abuse in human urine; combine 10 or 11 previously cleared test strips into single cup format; increase sample contact time from 20 seconds to 5 minutes; used by healthcare professionals in clinical settings; provides qualitative results for drug presence; aids in clinical decision-making regarding substance use.

## Clinical Evidence

Bench testing only. Submitter provided design control activities summary, risk analysis, and verification/validation data to support the modification of the test format and sample contact time.

## Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Form factor: test cup containing up to 10 or 11 individual drug analyte test strips. Analyte detection via visual colored line formation. No energy source required. Standalone device.

## Regulatory 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

- Rapid Drugs of Abuse Single and Multiple Test Panels (k003809)
- MICROMEDIC Drugs of Abuse Panel Test (k033566)
- RapidBUP Test Strip / RapidOXY Test Strip (k051958)

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k162395

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): MP DOA-10 Panel Test Cup and MP DOA-11 Panel Test Cup.

1. The name and 510(k) numbers of the SUBMITTER'S previously cleared devices.

k003809 Rapid Drugs of Abuse Single and Multiple Test Panels
k033566 MICROMEDIC Drugs of Abuse Panel Test
k051958 RapidBUP Test Strip / RapidOXY Test Strip

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.

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.

The changes were to combine previously cleared, prescription use, drugs of abuse test strips into a new test format that combines either 10 or 11 different tests into a single cup format as well as increase the total time the test strips are in contact with the sample matrix. The predicate devices are labeled for 20 seconds of contact with the sample matrix; the new device is labeled for 5 minutes of contact with the sample matrix.

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

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.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO/K162395](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO/K162395)

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