MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

K060417 · Quantimetrix Corp. · DIF · Mar 21, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060417
• Device Name: MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
• Applicant: Quantimetrix Corp.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The Urine Drugs of Abuse Control is intended for use as an assayed quality control material to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

Device Story

Urine Drugs of Abuse Control; liquid-based quality control material; used in clinical laboratories to monitor precision of toxicology testing procedures; modification adds Lysergic Acid Diethylamide (LSD) to existing control panel; device provides known concentrations of analytes to verify assay performance; healthcare providers use results to validate accuracy/precision of patient drug screening tests.

Clinical Evidence

No clinical data provided; device is a quality control material for in vitro diagnostic use. Bench testing only.

Technological Characteristics

Liquid control material for urine toxicology screening. Formulated to contain specific drugs of abuse for performance monitoring of screening assays. Standalone product; no software or electronic components.

Indications for Use

Indicated for use as an assayed quality control material for monitoring precision of laboratory urine toxicology testing procedures for clinical laboratory personnel.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

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 k060417

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.) k873467
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 adding Lysergic Acid Diethylamide (LSD) to the marketed Urine Drugs of Abuse Control.

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) 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.