MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT

K040758 · Microgenics Corp. · DIF · May 28, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040758
• Device Name: MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
• Applicant: Microgenics Corp.
• Product Code: DIF · Clinical Toxicology
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine.

Device Story

MGC DAU Control Sets are liquid, human urine-based control materials containing stabilizers and preservatives; offered in three configurations (Primary, Clinical, Select) with varying analyte concentrations. Used in clinical laboratory settings by technicians to validate drug of abuse assays. Controls are provided at two levels (Low and High) to verify assay performance. Healthcare providers use the results to ensure the accuracy and reliability of patient drug testing. Benefits include standardized quality control for toxicology screening, ensuring consistent assay performance and reliable clinical decision-making regarding drug presence.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of physical properties and intended use to the predicate device.

Technological Characteristics

Liquid control material prepared in human urine matrix with added stabilizers and preservatives. Two levels (Low and High) provided. Storage at 2°C to 8°C. No software or electronic components.

Indications for Use

Indicated for use as unassayed control material for the validation of drug of abuse assays performed using human urine samples.

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.

Predicate Devices

• Multi-Drug Control Set (K951135)

Submission Summary (Full Text)

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# SECTION II

## 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.

510(k) Number: K646758

### Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: [phone] Facsimile: [phone]

## Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: [phone] Facsimile: [phone]

#### Preparation Date:

March 23, 2004

#### Device Information:

| Device Classification Name: | Drug Mixture Control Materials |
|-----------------------------|----------------------------------------------------|
| Device Description | Clinical toxicology control material |
| Proprietary Name: | MGC DAU Control Sets: Primary, Clinical and Select |
| Regulation Number: | 21 CFR§862.3280 |
| Product Code: | DIF |
| Regulatory Class: | Class I |

#### Predicate Devices:

Evaluation of the data and results enclosed herein demonstrate that each configuration of the MGC DAU Control Sets is substantially equivalent in form and function to the Muli-Drug Control Set (K951135) for its stated intended use.

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## Device Description:

Each configuration of the MGC DAU Control Sets is prepared in a human wine matrix, with stabilizers and preservatives added. As is shown in the table below, the MGC DAU Control Set is offered in three configurations differing only in the concentration and number of analytes offered.

| Configuration | Drug | Low (ng/mL) | High (ng/mL) |
|---------------|-------------------|-------------|--------------|
| Primary | Benzoylecgonine | 225 | 375 |
| | EDDP | 750 | 1250 |
| | d-Methamphetamine | 750 | 1250 |
| | Methadone | 225 | 375 |
| | Methaqualone | 225 | 375 |
| | Opiates | 1500 | 2500 |
| | Benzodiazepenes | 225 | 375 |
| | Phencyclidine | 19 | 31 |
| | Propoxyphene | 225 | 375 |
| | Barbituates | 225 | 375 |
| Clinical | Benzoylecgonine | 225 | 375 |
| | EDDP | 75 | 125 |
| | d-Methamphetamine | 375 | 625 |
| | Methadone | 225 | 375 |
| | Methaqualone | 225 | 375 |
| | Opiates | 225 | 375 |
| | Benzodiazepenes | 225 | 375 |
| | Phencyclidine | 19 | 31 |
| | Propoxyphene | 225 | 375 |
| | Barbituates | 225 | 375 |
| Select | 6-Acetylmorphine | 7.5 | 12.5 |
| | Benzoylecgonine | 112.5 | 187.5 |
| | LSD | 0.3 | 0.7 |
| | MDMA | 375 | 625 |
| | Benzodiazepenes | 225 | 375 |

## Intended Use:

The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine.

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## Comparison to Predicate Device(s):

The MGC DAU Control Set is substantially equivalent to the Multi-Drug Control Set (K951135), also manufactured by Microgenics and previously cleared by FDA, for its stated intended use.

| Device<br>Characteristics | Subject Device | Predicate Device (K951135) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The MGC DAU Control Set consists<br>of unassayed controls intended for use<br>in the validation of drug of abuse<br>assays performed using human urine. | The Multi-Drug Controls are for use<br>as unassayed control material with<br>drugs of abuse assays. |
| Analytes<br>(by configuration) | Primary:<br>Benzoylecgonine<br>EDDP<br>d-Methamphetamine<br>Methadone<br>Methaqualone<br>Opiates1<br>Benzodiazapenes2<br>Phencyclidine<br>Propoxyphene<br>Barbituates3<br><br>Clinical:<br>Benzoylecgonine<br>EDDP<br>d-Methamphetamine<br>Methadone<br>Opiates1<br>Benzodiazapenes2<br>Phencyclidine<br>Propoxyphene<br>Barbituates3<br><br>Select:<br>6-Acetylmorphine<br>Benzoylecgonine<br>LSD<br>MDMA<br>Benzodiazapenes4 | Benzoylecgonine<br>EDDP<br>LSD<br>d-Methamphetamine<br>Methadone<br>Methaqualone<br>Opiates1<br>Benzodiazapenes4<br>Phencyclidine<br>Propoxyphene<br>Barbituates3 |
| Matrix | Urine | Urine |
| Control Form | Liquid | Liquid |
| Control Levels | Two: Low and High | Two: Low and High |
| Storage | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date |
| Stability | Until expiration date noted on vial<br>label | Until expiration date noted on vial<br>label |

Morphine 2 Oxazepam Secobarbital Nitrazepam

## Summary:

The information provided in this pre-market notification demonstrates that each configuration of the MGC DAU Control Set is substantially equivalent in form and function to the Multi-Drug Control Set (K951135) for its stated intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate devices. The information supplied in

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this pre-market notification provides reasonable assurance that each configuration of the MGC DAU Control Set is safe and effective for its stated intended use.

1. September 19.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, which is the main emblem of the department.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 8 2004

David Casal, Ph.D Vice-President, Clinical, Regulatory and Quality Affairs Microgenics Corp. 46360 Fremont Blvd. Fremont, CA 94538

Rc: k040758

Trade/Device Name: MGC DAU Control Sets: Primary, Clinical and Select Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: March 23, 2004 Received: April 12, 2004

Dear Dr. Casal:

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 adultcration.

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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## Page 2

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.

Jean M. Cooper, US, Div.

Jean M. Cooper, MS. 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): K040758

MGC DAU Control Sets: Primary, Clinical and Select Device name:

#### Indications for Use:

The MGC DAU Control Set consists of controls intended for use in the validation of drug of abuse assays performed using human urine.

Prescription Use _ ಸ್ (Part 21 CFR §801 Subpart D) AND/OP.

Over-the Counter Use (21 CFR §807 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)

Dberto

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k040758

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