DRI ECSTASY URINE CALIBRATORS

K012109 · Microgenics Corp. · DLJ · Aug 27, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012109
• Device Name: DRI ECSTASY URINE CALIBRATORS
• Applicant: Microgenics Corp.
• Product Code: DLJ · Clinical Toxicology
• Decision Date: Aug 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The DRI® Ecstasy Urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay.

Device Story

DRI Ecstasy Urine Calibrators are human urine-based, ready-to-use liquid calibrators spiked with known quantities of 3,4-methylenedioxymethamphetamine (MDMA). Available in 250, 500, 750, and 1000 ng/mL concentrations; the 500 ng/mL calibrator serves as the qualitative cutoff reference. Used in clinical laboratory settings by technicians to calibrate the DRI Ecstasy Immunoassay. Calibration ensures accurate performance of the immunoassay, allowing healthcare providers to reliably identify the presence of MDMA in patient urine samples for diagnostic or screening purposes.

Clinical Evidence

Bench testing only. Performance evaluated through traditional laboratory studies assessing precision, stability, and accuracy.

Technological Characteristics

Human urine-based matrix; ready-to-use liquid form. Contains known concentrations of 3,4-methylenedioxymethamphetamine (MDMA). Designed for use with DRI Ecstasy Immunoassay. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the calibration of the DRI Ecstasy Immunoassay in human urine samples to distinguish positive from negative samples at a 500 ng/mL cutoff.

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

• DRI Multi-Drug Calibrators (K983159)

Submission Summary (Full Text)

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KO12109

AUG 2 7 2001

Image /page/0/Picture/2 description: The image shows the logo for "microgenics". The logo features a circular design on the left, composed of small, petal-like shapes arranged in a spiral pattern. To the right of the circular design is the word "microgenics" in a bold, sans-serif font. A horizontal line underlines the word, adding emphasis to the brand name.

### 510(k) Summary

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

The assigned 510(k) number is: K01

## Submitter Information (21 CFR 807.92(a)(1))

| Submitter: | Microgenics Corporation<br>46360 Fremont Boulevard<br>Fremont, CA 94538<br>phone: [phone]<br>fax: [phone] |
|------------|-------------------------------------------------------------------------------------------------------------------------|
|------------|-------------------------------------------------------------------------------------------------------------------------|

Sherric Rinne Contact: Regulatory Specialist

July 3, 2001 Summary date:

## Name of Device and Classification (21 CFR 807.92(x)(2))

| Name (trade): | DRI ECSTASY URINE CALIBRATORS® |
|---------------|--------------------------------|
| Name (usual): | Ecstasy Urine Calibrators |

Calibrator, Drug Specific; 21 CFR 862.3200, Class II, DJL (91) Classification:

#### Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3))

DRI Ecstasy Urine Calibrators are substantially equivalent to DRI Multi-Drug Calibrators (Microgenics Corporation, Fremont, CA), cleared under premarket notification K983159

#### Description of Device (21 CFR 807.92 (a)(4))

DRI Ecstasy Urine Calibrators are human urine-based and ready to use. They are prepared by spiking negative urine matrix with known quantities of 3,4-methylenedioxymethamphetamine (MDMA). The DRI Ecstasy 500 ng/mL Calibrator is used as the qualitative cutoff reference for distinguishing "positive" from "negative" samples.

The DRI Ecstasy Calibrators available are as follows"

250 ng/mL Calibrator 500 ng/mL Calibrator 750 ng/mL Calibrator 1000 ng/mL Calibrator

#### Intended Use (21 CFR 807,92 (a)(5))

The DRI Ecstasy urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay

#### Microgenics Corporation

48360 Fremont Boulevard, Fremont, CA 94538 USA O Tel: [phone] O Fax: [phone] Technical Service/Customer Service [phone]

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## Similarities to the Predicate(s) (21 CFR 807,92 (a)(6))

The DRI Ecstasy Urine Calibrators are similar in intended use, matrix, and performance to the DRI Multi-Drug Urine Calibrators.

## Brief Discussion of Nonelinical/Clinical Data (21 CFR 807.92(b)(1, 2))

The DRI Ecstasy Urine Calibrators were evaluated via a series of traditional laboratory studies. These studies included the performance characteristics of precision, stability, and accuracy.

## Performance Data - Conclusions (21 CFR 807.92 (b)(3))

The DRI Ecstasy Enzyme Immunoassay has been shown to be substantially equivalent to the predicate device, and safe and effective for its intended use.

The DRI Ecstasy urine calibrators were evaluated via a series of traditional laboratory studies. These studies included the performance characteristics of precision, stability, and accuracy.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle with its wings spread, represented by three curved lines. The eagle design is black, and the text is also in black.

AUG 2 7 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherrie Gene Rinne Regulatory Specialist Microgenics Corporation 46360 Fremont Boulevard Fremont, CA 94538

Re: K012109

> Trade/Device Name: DRI® Ecstasy Urine Calibrators Regulation Number: 21 CFR 862.3200 Regulatory Class: II Product Code: DLJ Dated: July 3, 2001 Received: July 6, 2001

Dear Ms. Rinne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 1 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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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# STATEMENT OF INTENDED USE

510(K) Number (if known): __ KO12 109 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: DRI® Ecstasy Urine Calibrators

#### Indications for Use:

The DRI® Ecstasy Urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: underline;">✓</span> | OR | Over-the-Counter Use | <span style="text-decoration: underline;">__</span> |
|----------------------|----------------------------------------------------|----|----------------------|-----------------------------------------------------|
| (Per 21 CFR 801.109) | | | | |

| | <div> Kesia Alexander <i>for</i> Sean Cupit </div> <div>(Division Sign-Off)</div> |
|--|--------------------------------------------------------------------------------------------------|
|--|--------------------------------------------------------------------------------------------------|

Division of Clinical Laboratory Devices

| Microgenics Corporation | 510(k) Number | K012109 | Page 13 of 18 |
|-------------------------------|---------------|---------|---------------|
| DRI Ecstasy Urine Calibrators | | | |