LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC

K014069 · Princeton BioMeditech Corp. · DIO · Jun 10, 2002 · Clinical Toxicology

Device Facts

• Record ID: K014069
• Device Name: LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
• Applicant: Princeton BioMeditech Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

LifeSign Home Drug Test (COC) is designed for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cutoff of 300 ng/mL in human urine to assist in screening of drugs of abuse samples at home. Status Stik™ COC is designed for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cutoff of 300 ng/mL in human urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use.

Device Story

One-step immunochromatographic test for rapid, qualitative detection of cocaine metabolite (benzoylecgonine) in human urine. Device formats include sticks, cards, and strips. User applies urine sample to device; visual readout indicates presence or absence of cocaine metabolite based on 300 ng/mL cutoff. Used in home settings (LifeSign) or professional clinical settings (Status Stik, AccuSign, AccuStik, AccuStrip) for drug screening. Provides immediate visual results to assist healthcare providers or consumers in identifying potential drug use.

Clinical Evidence

Bench testing only. Comparative study of 100 specimens (50 positive, 50 negative) showed 100% correlation with predicate device. Consumer study for LifeSign Home Drug Test (COC) reported >96% overall accuracy.

Technological Characteristics

Immunochromatographic assay; lateral flow format (stick, card, or strip); visual qualitative readout; 300 ng/mL cutoff; non-electronic; in vitro diagnostic.

Indications for Use

Indicated for qualitative detection of cocaine metabolite (benzoylecgonine) in human urine at 300 ng/mL cutoff for screening of drugs of abuse. Intended for home use (LifeSign) or professional in vitro diagnostic use (Status Stik/AccuSign/AccuStik/AccuStrip).

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

• StatusDS™DOA10 (K990786)

Submission Summary (Full Text)

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## 510(k) Summary

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

The assigned 510(k) number is: 14060

- 1. Date of Summary: Nov.30, 2001
- 2. Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1. Monmouth Jct., NJ 08852 PHONE [phone] FAX Contact Person: Jemo Kang
- 3. Device Name: Trade Name: LifeSign®Home Drug Test (COC) Common or Usual Name: Immunoassay for detection of cocaine in human urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DIO for Enzyme Immunoassay)
- 4. Identification of legally marketed device to which claims equivalence: k990786; StatusDS™DOA10(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
- 5. Device Description: LifeSign Home Drug Test (COC) is simple one step immunochromatographic test for the rapid, qualitative detection of cocaine.
- 6. Intended Use: LifeSign Home Drug Test (COC) is designed for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cutoff of 300 ng/mL in human urine to assist in screening of drugs of abuse samples at home.
- 7. Substantial Equivalence: LifeSign®Home Drug Test (COC) is substantially equivalent to k990786; Status DS "DOA10. Both products use the same assay principle and immunochromatographic assay to detect cocaine metabolite qualitatively. The detection cutoff level is the same. The tests demonstrated 100 % correlation when 100 specimens (50 negative and 50 positive) were compared. The differences are that LifeSign®Home Drug Test (COC) detects cocaine use only, while StatusDS "DOA10 detects nine other drugs of abuse in addition to COC, and different antibody is used for cocaine detection.
- 8. Consumer Study: In a consumer study, LifeSign® Home Drug Test (COC) showed over 96% overall accuracy.
- Conclusion: The device is substantially equivalent to the legally marketed device k990786. Status DS""DOA10 (MET/OPI/COC/THC/PCP/BZO/ BAR/MTD/TCA/AMP).

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## 510(k) Summary

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

The assigned 510(k) number is: 1601-1067

1. Date of Summary: Nov.30, 2001

2. Submitted by: Princeton BioMeditech Corperation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE [phone] FAX [phone] Contact Person: Jemo Kang

3. Device Name: Trade Names: Stick Device: Status Stik™ COC, AccuSign® Stik COC, AccuStik™ COC Card Device: AccuSign® COC, Status DS™ COC Strip Test: AccuStrip™ COC Common or Usual Name: Immunoassay for detection of cocaine in human urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DIO for Enzyme Immunoassay)

- 4. Identification of legally marketed device to which claims equivalence: k990786; StatusDS™DOA10(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
- 5. Device Description: Status Stik" COC is simple one step immunochromatographic test for the rapid, qualitative detection of cocaine.
- 6. Intended Use: Status Stik™ COC is designed for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cutoff of 300 ng/mL in human urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use.
- 7. Substantial Equivalence: Status Stik" COC is substantially equivalent to k990786; Status DS™DOA10. Both products use the same assay principle and immunochromatographic assay to detect cocaine metabolite qualitatively. The detection cutoff level is the same. The tests demonstrated 100 % correlation when 100 specimens (50 negative and 50 positive) were compared. The differences are that Status Stik™ COC detects cocaine use only, while StatusDS™DOA10 detects nine other drugs of abuse in addition to COC, and different antibody is used for cocaine detection.
- Conclusion: The device is substantially equivalent to the legally marketed device k990786. Status DS "DOA10 (MET/OPI/COC/THC/PCP/BZO/ BAR/MTD/TCA/AMP).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jemo Kang, Ph.D. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905

JUN 1 0 2002

Re: k014069

> Trade/Device Name: LifeSign®Home Drug Test (COC) Status Stik™ COC, AccuSign®Stik COC, AccuStik™ COC, AccuSign® COC, Status DSTM COC, Strip: AccuStrip™ COC Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: April 9, 2002 Received: April 10, 2002

Dear Dr. Kang:

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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Page 2 -

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 i 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 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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Page of

KO14067 510(k) Number (if known):

Device Name: Stick: Status Stik™ COC, AccuSign®Stik COC, AccuStik™ COC Card: AccuSign® COC, Status DSTM COC Strip: AccuStrip™ COC

Indications For Use:

Immunoassay for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of abuse samples. For In vitro Diagnostic Use

Sean Cooges
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014069

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Professional Use: Prescription Use:_X (Per 21 CFR 801.109)

OR

Over The Counter Use:

(Optional Format 1-2-96) Page of of of of a

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Page of

510(k) Number (if known): [ 0 1406 }

Device Name: LifeSign®Home Drug Test (COC)

Indications For Use:

Immunoassay for the qualitative detection of cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of abuse at home. For In vitro Diagnostic Use

Jean Cooper

(Division -Off)
Division or inical Laboratory Devices
510(k) Num: K014069

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

## Concurrence of CDRH Office of Device Evaluation (ODE)

Professional Use:_

Prescription Use:_ (Per 21 CFR 801.109) OR

Over The Counter Use: X

(Optional Format 1-2-96)