AMEDITECH IMMU TEST DRUG SCREEN PANEL

K040092 · Ameditech, Inc. · DKZ · Mar 8, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040092
• Device Name: AMEDITECH IMMU TEST DRUG SCREEN PANEL
• Applicant: Ameditech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Mar 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The Ameditech ImmuTest Drug Screen Panel is a one-step panel immunoassay for the qualitative detection of amphetamine, cocaine metabolite (benzovlecgonine), methamphetamine, opiates, phencyclidine, and THC in human urine. The cutoff concentrations for this panel test are amphetamine at 1000 ng/ml, cocaine metabolite at 300 ng/ml, methamphetamine at 500 ng/ml, opiates at 2000 ng/ml, phencyclidine at 25 ng/ml, and THC at 50 ng/ml. This test kit is used to obtain a visual, qualitative results and is intended for professional use.

Device Story

Device modification involving placement of six previously cleared, unmodified devices into a single plastic test strip holder. Modification does not alter fundamental scientific technology or intended use. Device intended for clinical use; operated by healthcare professionals. Output remains consistent with original cleared device performance.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of lateral flow immunoassay drug screening tests.

Technological Characteristics

Modification consists of a plastic test strip holder containing six unmodified, previously cleared devices. Fundamental scientific technology remains unchanged. No new materials or energy sources introduced.

Indications for Use

Indicated for professional use for qualitative detection of amphetamine, cocaine metabolite, methamphetamine, opiates, phencyclidine, and THC in human urine at specified cutoff concentrations.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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 K_040092

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 (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 placing six unmodified devices in a plastic test strip holder.

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