MAS TOX CONTROL

K080085 · Thermo Fisher Scientific · DIF · Apr 30, 2008 · Clinical Toxicology

Device Facts

• Record ID: K080085
• Device Name: MAS TOX CONTROL
• Applicant: Thermo Fisher Scientific
• Product Code: DIF · Clinical Toxicology
• Decision Date: Apr 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

MAS Tox Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in the measurement of Benzodiazepines and Barbiturates in human serum and plasma and Tricyclic Antidepressants drugs (TCA) in human serum, plasma and urine. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Story

MAS Tox Control is a liquid, bovine plasma-based quality control material containing secobarbital, diazepam, and nortriptyline. Used in clinical laboratories to monitor assay performance for benzodiazepines, barbiturates, and tricyclic antidepressants. The product is provided in two- or three-level configurations. Users compare observed assay values against lot-specific target ranges provided in the package insert to ensure consistent performance of reagents and instruments. It is intended for prescription use.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) established a 2-year closed-vial shelf life and 20-day open-vial stability at 2-8°C. Value assignment ranges were determined using a minimum of 20 data points collected over five days (2 runs x 2 reps x 5 days) per instrument.

Technological Characteristics

Liquid control; bovine plasma base; analytes: secobarbital, diazepam, nortriptyline (≥ 99% purity); preservative: sodium azide; storage: 2-8°C; shelf life: 2 years (closed), 20 days (open).

Indications for Use

Indicated for use as a quality control material to monitor assay performance for Benzodiazepines and Barbiturates in human serum/plasma and Tricyclic Antidepressants in human serum, plasma, and urine.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 3 0 2008

ThermoFisher Scientific Division: Microgenics Corp. c/o Jack Rogers, Regulatory Affairs Manager 46360 Fremont Blvd. Fremont, CA 94538

Re: k080085 Trade Name: MAS Tox Control Regulation Number: 21 CFR §862.3280 Regulation Name: Clinical Toxicology Control Material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Code: DIF Dated: March 10, 2008 Received: March 11, 2008

Dear Mr. Rogers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K080085

Device Name: MAS Tox Control

## Indications for Use:

MAS Tox Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in the measurement of Benzodiazepines and Barbiturates in human serum and plasma and Tricyclic Antidepressants drugs (TCA) in human serum, plasma and urine.

Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benam

. Ision Sign-Off

Office of In Vitro Diagnostic Device Jvaluation and Safety

K080085

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