COCAINE

K013004 · Abbott Laboratories · DIO · Mar 13, 2002 · Clinical Toxicology

Device Facts

• Record ID: K013004
• Device Name: COCAINE
• Applicant: Abbott Laboratories
• Product Code: DIO · Clinical Toxicology
• Decision Date: Mar 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The Cocaine assay is used for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine with a cutoff of 300 ng/mL. For use in clinical laboratories. The Cocaine assay is calibrated with Benzoylecgonine and will detect cocaine and the major metabolites.

Device Story

In vitro diagnostic assay; qualitative analysis of benzoylecgonine in human urine. Homogeneous enzyme immunoassay; competition between specimen drug and G6PDH-labeled drug for antibody binding sites. Enzyme activity inversely proportional to drug concentration. Used in clinical laboratories; operated by laboratory personnel. Output provides preliminary analytical result for cocaine/metabolites; requires confirmation via GC/MS. Assists clinicians in diagnosis and treatment of cocaine use or overdose.

Clinical Evidence

Bench testing only. Method comparison performed on AEROSET® System vs. Emit II Cocaine assay (100% agreement) and GC/MS (87% agreement). Precision studies conducted with five control levels; total %CV ranged from 0.42% to 0.64%. Limit of detection (sensitivity) is 35 ng/mL.

Technological Characteristics

Homogeneous enzyme immunoassay; G6PDH enzyme label; competitive binding mechanism. Qualitative analysis. Cutoff 300 ng/mL. Designed for use on automated clinical chemistry analyzers (e.g., AEROSET® System).

Indications for Use

Indicated for qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine at 300 ng/mL cutoff in clinical laboratories. Used for diagnosis and treatment of cocaine use or overdose. Provides preliminary results requiring confirmation by alternate chemical method (e.g., GC/MS).

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Emit® II Cocaine assay (K902579)

Submission Summary (Full Text)

{0}------------------------------------------------

MAR 1 3 2002

K013004

# 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21

Irving, Texas 75038

Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs [phone] Fax [phone]

Date of Preparation of this Summary: Device Trade or Proprietary Name; Device Common/Usual Name or Classification Name:

November 21, 2001 Cocaine

Cocaine

DIO/Class II

Classification Number/Class:

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: K013004.

#### Test Description:

Cocaine is an in vitro diagnostic assay for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine. The assay is a homogencous enzyme immunoassay with a 300 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenasc (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity.

{1}------------------------------------------------

### Substantial Equivalence:

The Cocaine assay is substantially equivalent to the Emit® II Cocainc assay (K902579) on the SYVA® 30R Analyzer.

Both assays yield similar Performance Characteristics.

#### Similarities:

- ♥ Both assays are in vitro immunoassays.
- . Both assays can be used for the qualitative analysis of Cocaine.
- Both assays yield similar results. 방
- Both assays are based on the competition between drug in the specimen and drug labeled with the . enzyme glucosc-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.

#### Differences:

- Cocaine is a qualitative assay. Emit II Cocaine assay is a qualitative and semiquantitative assay. .
#### Intended Use:

The Cocaine assay is used for the qualitative analysis of benzoylecgonine (cocaine metabolite) in human urine with a cutoff of 300 ng/mL. For use in clinical laboratories.

The Cocaine assay is calibrated with Benzoylecgonine and will detect cocaine and the major metabolites.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Cocaine assay method comparison yielded acceptable correlation with the Emit II Cocainc assay on the SYVA-30R Analyzer. The concordance table shows 100% agreement. The Cocaine assay method comparison vielded acceptable correlation with GC/MS. The concordance table shows 87% agreement with GC/MS. The clinical specimens tested ranged from 56.8 to 70,040.0 ng/mL. Precision studies were conducted using the Cocaine assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verificr I is 0.48%, Cutoff Calibrator is 0.64%, Verificr II is 0.48%, - 25% of Cutoff Calibrator is 0.42%, and + 25% of Cutoff Calibrator is 0.47%. The Cocainc

{2}------------------------------------------------

assay cutoff is 300 ng/mL. The limit of detection (sensitivity) of the Cocaine assay is 35 ng/mL. These data demonstrate that the performance of the Cocaine assay is substantially equivalent to the performance of the Emit II Cocaine assay on the SYVA-30R Analyzer.

## Conclusion:

The Cocaine assay is substantially equivalent to the Emit II Cocaine assay on the SYVA-30R Analyzcr as demonstrated by results obtained in the studies.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 3 2002

Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038

Re: k013004 Trade/Device Name: Cocaine Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine test system Regulatory Class: Class II Product Code: DIO Dated: November 26, 2001 Received: November 28, 2001

Dear Ms. Simpson:

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.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and my 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 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

{5}------------------------------------------------

### 510(k) Number (if known): K013004

Device Name: ____ Cocaine

Indications For Use:

The Cocaine assay is used for the qualitative analysis of benzolecgonine (cocainc metabolite) in human urine with a cutoff of 300 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

The Cocainc assay is calibrated with Benzoylcegonine and will detect cocaine and the major metabolites.

The Cocaine assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Ke

Division Sign-Off) Division of Clinical Laboratory Levices 510(k) Number --

(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)