ON TRAK TESTCARD

K051235 · Varian, Inc. · DKZ · Jun 8, 2005 · Clinical Toxicology

Device Facts

• Record ID: K051235
• Device Name: ON TRAK TESTCARD
• Applicant: Varian, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The OnTrak TesTcard menus are various combinations of the different drugs that are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following: Amphetamines (d,l-amphetamine 1000 ng/mL), Barbiturates (secobarbital 200 ng/mL), Benzodiazepines (oxazepam 100 ng/mL), Cocaine metabolite (benzoylecgonine 300 ng/mL), Methamphetamine (d-methamphetamine 500 ng/mL), Morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), Tricyclic Antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-Δ9-THC-9-carboxylic acid 50 ng/mL). TesTcard products provide only preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Device Story

OnTrak TesTcard is an in vitro diagnostic device for qualitative drug screening in urine. Device utilizes microparticle capture inhibition; urine sample is absorbed into a pad and migrates via capillary action through reagent strips. Strips contain antibody-coated blue microparticles and immobilized drug conjugates. In absence of drug, microparticles bind to conjugates, forming blue bands. In presence of drug, microparticles bind to drug in sample, preventing band formation (negative result). A 'TEST VALID' band confirms proper test completion. Device is intended for professional use to provide preliminary results; positive results require confirmation by alternate chemical methods. Benefits include rapid, simultaneous multi-drug screening.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance of the previously cleared drug test strips.

Technological Characteristics

Microparticle capture inhibition assay. Device consists of reagent strips with antibody-coated blue microparticles and immobilized drug conjugates on a membrane. Form factor is a test card. No electronic components, software, or external energy sources required. Qualitative visual readout.

Indications for Use

Indicated for the qualitative detection of various combinations of 9 drugs using test strips.

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).

Predicate Devices

• On Trak TesTcard 9 (K051235)

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_051235

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, 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 various combinations of the different drugs that are 9 drugs test strips of the currently marketed On Trak TesTcard 9.

4. Comparison Information similarities 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 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 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.