PRECISET DAT AMPHETAMINE

K030826 · Quantimetrix Corp. · DIJ · Apr 3, 2003 · Clinical Toxicology

Device Facts

• Record ID: K030826
• Device Name: PRECISET DAT AMPHETAMINE
• Applicant: Quantimetrix Corp.
• Product Code: DIJ · Clinical Toxicology
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3550
• Device Class: Class 2

Intended Use

The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

Device Story

Preciset® DAT Amphetamine consists of liquid calibrators and controls in glass bottles; matrix is drug-free human urine with added preservative, stabilizer, and d-amphetamine analyte. Used in clinical toxicology settings to calibrate Roche Abuscreen® OnLine and COBAS INTEGRA® Amphetamine assays on automated clinical chemistry analyzers. Concentration levels are verified via GC/MS. Device enables accurate quantification of amphetamines in urine by clinical laboratory personnel; ensures assay performance within clinical chemistry workflows.

Clinical Evidence

Bench testing only. Accelerated stability studies (25°C and 37°C) and real-time stability studies were conducted to validate shelf life and opened-vial claims. Performance was verified using Roche immunoassays.

Technological Characteristics

Liquid calibrator/control in glass vials; matrix: drug-free human urine; additives: preservative, stabilizer, d-amphetamine. Concentration determined by GC/MS. Standalone reagent for use with automated clinical chemistry analyzers.

Indications for Use

Indicated for the calibration of Roche Abuscreen OnLine and COBAS INTEGRA Amphetamine assays for the determination of amphetamines in human urine samples using automated clinical chemistry analyzers.

Regulatory Classification

Identification

A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

Predicate Devices

• Emit® Calibrators/controls (Syva Company)

Reference Devices

• Roche Abuscreen® OnLine assays
• COBAS INTEGRA® Amphetamines (AMPS)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Quantimetrix Corporation. The logo consists of two overlapping circles with the letters "QC" inside, followed by the words "Quantimetrix Corporation" in a smaller font. Below the logo is the address "2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278-1205".

TEL [phone] or [phone]
FAX [phone] or [phone]

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

K 0308 210 The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

| Proprietary Name: | Preciset® DAT Amphetamine |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Calibrators/Controls |
| Classification Name: | Calibrators, Drug Mixture |
| Medical specialty: | Clinical Toxicology |
| Product Code: | DKB |
| Device class: | 2 |
| Regulation No: | 862.3200 |
| Manufacturer: | Quantimetrix Corporation<br>2005 Manhattan Beach Boulevard<br>Redondo Beach CA 90278<br>Phone: [phone] FAX: [phone] |
| Contact Persons: | Gebhard Neyer, Ph.D., Director of R&D, 310-536-0006 |
| Registration No: | 2020715 |

The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine

Drug concentration is determined using GC/MS. The Quantimetrix calibrator is substantially equivalent to the currently marketed Emit®

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## Calibrators/controls manufactured by Syva Company.

Both feature similar matrices, constituents and stability claims.

#### Intended Use

The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

### Performance Characteristics

Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators/controls. When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 3 2003

Gebhard Neyer, Ph.D. Director, Research & Development Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach, CA 90278

Re: k030826

Trade/Device Name: Preciset® DAT Amphetamine Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DIJ Dated: March 3, 2003 Received: March 14, 2003

Dear Dr. Neyer:

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. Iisting 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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page_1_of_____________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): 40308080

Device Name: _____________ Preciset® DAT Amphetamine

Preciset® DAT Amphetamine

Drug of Abuse Calibrators/Controls

# Indications For Use:

The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K030826 |

| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|

(Per 21 CFR 801.109) (Optional Format 1-2-96)(Optional Format 1-2-96)