EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5

K993755 · Syva Co. · DKB · Dec 21, 1999 · Clinical Toxicology

Device Facts

• Record ID: K993755
• Device Name: EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
• Applicant: Syva Co.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Emit Calibrator/Controls are used in the callbration of the Emit II Plus drugs-of-abuse assays. These standards may also be used as quality control materials based upon specified assay cutoff levels. The Emit Calibrator/Controls are used for the Emit II Plus Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Methadone, Methaqualone, Mononclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine, and Propoxyphene Assays.

Device Story

Emit Calibrators/Controls (Levels 0-5) are ready-to-use liquid standards in human urine matrix; contain specific concentrations of drugs-of-abuse analytes (e.g., benzoylecgonine, morphine, THC-COOH). Used in clinical laboratory settings to calibrate Emit II Plus assays and serve as quality control materials. Analytes are traceable to GC/MS confirmation. Healthcare providers use assay results to detect presence of drugs-of-abuse in patient urine samples; supports clinical decision-making regarding substance use. Benefits include standardized assay performance and reliable detection of drug analytes.

Clinical Evidence

Bench testing only. Studies confirmed analytes do not cross-react or interfere with Emit II Plus assays. Products demonstrated sufficient stability for intended use. Nominal analyte concentrations are traceable to GC/MS confirmation.

Technological Characteristics

Ready-to-use liquid calibrators/controls in human urine matrix. Contains various drug analytes (benzoylecgonine, lormetazepam, methamphetamine, methaqualone, morphine, 11-delta 9-THC-9-COOH, phencyclidine, propoxyphene, secobarbital). No unique technical characteristics; standard clinical toxicology calibrator design.

Indications for Use

Indicated for use as calibration and quality control materials for Emit II Plus drugs-of-abuse assays to detect barbiturates, benzodiazepines, cannabinoids, cocaine metabolite, methadone, methaqualone, amphetamines/methamphetamine, opiates, phencyclidine, and propoxyphene in human urine.

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 Calibrator Level 0
• Emit Calibrators A Level 1 and 2
• Emit Calibrators B Level 1 and 2

Submission Summary (Full Text)

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DEC 2 1 1999

## DADE BEHRING

P.2

SYVA COMPANY P.O. Box 49013 San Jose, CA 95161-9013

3403 Yerba Buena Road San Jose, CA 95135 Tel: [phone]

### 510 (k) SUMMARY

This summary of \$10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

The assigned 510(k) number is:

The device is the Emit Calibrators' Controls , Lavels 0-5. The common or usual name is calibrators and/ or controls. The classification name is Clinical Toxicology Calibrator, 91 DKB.

The device is substantially equivalent to the following: Emit Calibrator Level O, Emit Calibrators A Level 1 and 2 and Emit Calibrators B Level 1 and 2.

The Emit Calibrators/Controls contain various combinations of the following drugs at varying concentrations: benzoyecgonine, lormetazepam, methamphetamine, methaqualone, morphine, 11-delta 9-THC-9-COOH, phencyclidine, propoxyphene and secobarbital. They are intended to be used with the following respective Emit II Plus assays for detecting: eocaine metabolite, benzodiazepines, methadone, amphetamines, methaqualone, opiates, cannabinoids, phencyclidine, propoxyphene and barbiturates.

The Emit Calibrators Controls are provided as ready-to-use liquids in a human urine matrix and they have characteristics common to a variety of commercially available calibrators and/or controls intended for use with assays for detecting drugs of-abuse. The do not have any expecially unique technical characteristics.

Where applicable, calibrators include concentrations of analytes that are required by the US Substance Abuse and Mental Health Services Administration (SAMHSA) for detecting drugs-ofabuse.

Nominal concentrations of each analyte are traceable to confirmation by GC/MS.

Studies have shown that none of the analytes cross react or otherwise interfere with the use of any of the Emit II Plus assays for which these products are intended and that the products are sufficiently stable for their intended uses.

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DEC 2 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul L. Rogers Jr. Senior Manager, Regulatory Affairs Syva Company 3403 Yerba Buena Road San Jose, California 95135

Re: K993755 Trade Name: Emit® Calibrator/Control Level 0 Emit® Calibrator/Control Level 1 Emit® Calibrator/Control Level 2 Emit® Calibrator/Control Level 3 Emit® Calibrator/Control Level 4 Emit® Calibrator/Control Level 5 Regulatory Class: II Product Code: DKB Regulatory Class: I Product Code: DIF Dated: November 4, 1999 Received: November 5, 1999

Dear Mr. Wells:

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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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# 510(k) Number (if known): K993755

Device Name:

Emit® Calibrator/Control Level 0 Emit® Calibrator/Control Level 1 Emit® Calibrator/Control Level 2 Emit® Calibrator/Control Level 3 Emit® Calibrator/Control Level 4 Emit® Calibrator/Control Level 5

#### Indications for Use:

The Emit Calibrator/Controls are used in the callbration of the Emit II Plus drugs-of-abuse assays. These standards may also be used as quality control materials based upon specified assay cutoff levels. The Emit Calibrator/Controls are used for the Emit II Plus Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Methadone, Methaqualone, Mononclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine, and Propoxyphene Assays.

Note: The above listed assays are currently in the process of being filed for 510(k) clearance,

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Dean Cooper

Division Sign-Off) on of Clinical Laboratory Devices 55