PRECISET DAT PLUS

K021393 · Quantimetrix Corp. · DKB · Jun 13, 2002 · Clinical Toxicology

Device Facts

• Record ID: K021393
• Device Name: PRECISET DAT PLUS
• Applicant: Quantimetrix Corp.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Device Story

Preciset® DAT Plus is a liquid calibrator set consisting of drug-free human urine spiked with preservatives, stabilizers, and specific drugs of abuse (methamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids) at six distinct levels. Used in clinical laboratories to calibrate automated clinical chemistry analyzers for drug testing. Concentrations are verified via GC/MS. The device ensures accurate quantification of drugs of abuse in patient urine samples, supporting clinical toxicology decision-making.

Clinical Evidence

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

Technological Characteristics

Liquid calibrator in glass bottles; matrix consists of drug-free human urine with added preservatives, stabilizers, and drugs of abuse; six distinct concentration levels; concentrations determined by GC/MS.

Indications for Use

Indicated for the calibration of Roche drugs of abuse assays in human urine samples using automated clinical chemistry analyzers.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). 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.

Predicate Devices

• Emit® Calibrators/controls (Syva Company)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a date written in bold, black font. The date is 'JUN 13 2002'. The month is abbreviated to three letters, followed by the day and then the year.

Image /page/0/Picture/1 description: The image shows the logo for Quantimetrix Corporation. The logo consists of two interlocking letter C's above the company name. The address "2005 Manhattan Beach Boulevard Redondo Beach, CA 90278-1205" is printed to the right of the company name.

[phone] or (310) 57 [phone] or (310) 5

### 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

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

| Proprietary Name: | Preciset® DAT Plus |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 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 Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids

Drug concentrations are determined using GC/MS.

Quantimetrix Corp.

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The Quantimetrix calibrator is substantially equivalent to the currently marketed Emit® Calibrators/controls manufactured by Syva Company.

Both feature similar matrices, constituents and stability claims.

#### Intended Use

a

The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse 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. 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wing-like shapes, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Garther Road Rockville MD 20850

# JUN 1 3 2002

Dr. Gebhard Neyer Director, Research & Development Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach, CA 90278-1205

Re: k021393

Trade/Device Name: Preciset® DAT Plus Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: May 1, 2002 Received: May 2, 2002

Dear Dr. Gebhard:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of__1__

510(k) Number (if known):__KOZ1393

Device Name: Preciset® DAT Plus

Druq of Abuse Calibrators

# Indications For Use:

The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Frank

(Division Sign-Of)
Division of Clinical Laboratory Devices
510(k) Number K021393

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over-The-Counter Use_

(Per 21 CFR 801.109)

(Optional Format 1-2-96)