← Product Code [DIS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS) · K033334

# PROFILE -ER (K033334)

_Medtox Diagnostics, Inc. · DIS · Nov 10, 2003 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K033334

## Device Facts

- **Applicant:** Medtox Diagnostics, Inc.
- **Product Code:** [DIS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS.md)
- **Decision Date:** Nov 10, 2003
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.3150
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The 3 Panel TCA/BAR/BZO is a one-step immunochromatographic test for the rapid, qualitative detection of tricyclic antidepressants, barbiturates and benzodiazepines and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations: Tricyclis antidepressants (Desipramine) - 50 ng/ml Barbiturates (Phenobarbital)-200 ng/ml Benzodiazepines (Nordiazepam)-300 ng/mL This product is not for over-the-counter-sale The 3 Panel provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result

## Device Story

Profile-ER TCA/BAR/BZO is a one-step immunochromatographic assay for qualitative drug screening. Input: human urine sample. Principle: lateral flow immunoassay using specific antibodies to detect drug metabolites at defined cutoff concentrations (TCA: 50 ng/mL; BAR: 200 ng/mL; BZO: 300 ng/mL). Output: visual qualitative result (presence/absence of drug). Used in clinical settings by healthcare professionals. Provides preliminary screening data; requires confirmatory testing via GC/MS for clinical decision-making. Benefits: rapid identification of potential drug presence to guide further diagnostic or clinical management.

## Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of immunochromatographic drug screening assays.

## Technological Characteristics

In vitro diagnostic test device; utilizes test bands for drug detection; modification involves removal of specific methadone test band; fundamental scientific technology unchanged.

## Regulatory Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). A barbiturate 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

To: THE FILE

RE: DOCUMENT NUMBER K033334

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.)
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.

This change was for removal of the methadone test band from Profile-ER II.

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

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K033334](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIS/K033334)

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