ONTRAK TESTCUP II AND ONSITE CUPKIT

K033902 · Varian, Inc. · DKZ · Jan 20, 2004 · Clinical Toxicology

Device Facts

• Record ID: K033902
• Device Name: ONTRAK TESTCUP II AND ONSITE CUPKIT
• Applicant: Varian, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Jan 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations. Cutoff Concentrations: Amphetamines: 1000 ng/mL; Benzodiazepines: 200 ng/mL; Cocaine metabolite: 300 ng/mL; Methamphetamine: 500 ng/mL; Morphine: 300 ng/mL; Morphine (M2K): 2000 ng/mL; Phencyclidine (PCP): 25 ng/mL; Tetrahydrocannabinols (THC): 50 ng/mL. TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific analytical method must be used in order to obtain a confirmed analytical result.

Device Story

OnTrak TesTcup II and OnSite CupKit are in vitro diagnostic urine drug test cups for professional use. Device utilizes microparticle capture inhibition immunoassay. Urine collected in cup; drug profile card inserted into lid. Capillary action draws urine into card, reacting with antibody-coated microparticles and drug conjugate on membrane. In absence of drug, antibody binds conjugate, forming blue band. Presence of drug inhibits binding, preventing blue band formation (preliminary positive). 'VALID' band confirms test function. Results interpreted visually by clinician. Provides preliminary screening; requires confirmatory testing (e.g., GC/MS) for clinical decision-making. Benefits include rapid, point-of-care detection of drug presence.

Clinical Evidence

Clinical evaluation performed in a SAMHSA-certified laboratory comparing device results to GC/MS reference methods and predicate devices (OnTrak TesTstik 2). Study included clinical specimens across all drug analytes. Results demonstrated high concordance with GC/MS and predicate devices, with overall percent agreement ranging from 96% to 100% across different drug classes.

Technological Characteristics

Modified strip casing configuration; attachment of strips to cap; different casing materials compared to predicate. Fundamental scientific technology unchanged.

Indications for Use

Indicated for professional use for qualitative detection of amphetamines, benzodiazepines, cocaine metabolite, methamphetamine, morphine, PCP, and THC in human urine at specified cutoff concentrations. Provides preliminary analytical results requiring confirmation by a more specific method.

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

To: THE FILE

RE: DOCUMENT NUMBER K033902

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 reconfiguration of strip casing and attachment of strips to cap rather than cup.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and same strips but some different casing materials.
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.