LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC

K014067 · Princeton BioMeditech Corp. · DIO · Jun 10, 2002 · Clinical Toxicology

Device Facts

• Record ID: K014067
• Device Name: LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/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 (THC/COC) is designed for the qualitative detection of THC metabolite, 11-nor-A-THC-9-carboxylic acid, at the cutoff of 50 ng/mL and 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

The device is a simple, one-step immunochromatographic test for the rapid, qualitative detection of THC and cocaine metabolites in human urine. It functions as an immunoassay; urine samples are applied to the test device (stick, card, or strip format). The presence of specific drug metabolites is detected via antibody-antigen binding, resulting in a visual qualitative readout. The device is used for screening purposes to assist in identifying drug abuse. It is intended for both home use (OTC) and professional use. The healthcare provider or user interprets the visual output to determine the presence of metabolites above established cutoff levels, which informs subsequent clinical or personal decision-making regarding drug screening.

Clinical Evidence

Bench testing only. A consumer study reported over 96% overall accuracy. Comparative testing against the predicate device using 100 specimens (50 negative and 50 positive for each drug) demonstrated 100% correlation.

Technological Characteristics

Immunochromatographic assay; qualitative detection; lateral flow format (stick, card, or strip). Detects THC metabolite (11-nor-A-THC-9-carboxylic acid) at 50 ng/mL and cocaine metabolite (benzoylecgonine) at 300 ng/mL. Uses specific antibodies for THC and cocaine detection.

Indications for Use

Indicated for qualitative detection of THC metabolite (11-nor-A-THC-9-carboxylic acid) at 50 ng/mL and cocaine metabolite (benzoylecgonine) at 300 ng/mL in human urine to assist in screening for drugs of abuse. Intended for home use or professional use.

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

• Status DS™ 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: KO 14067

1. Date of Summary: Nov.30, 2001

Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE [phone] FAX [phone]

Contact Person: Jemo Kang

3. Device Name

Trade Names: LifeSign® Home Drug Test, Marijuana & Cocaine (THC/COC) Common or Usual Name: Immunoassay for detection of THC and cocaine in human urine

Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DIO for Enzyme Immunoassay)

- 4. Identification of legally marketed device to which claims equivalence: k990786; Status DS ™ DOA10(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
- 5. Device Description: LifeSign® Home Drug Test (THC/COC) is simple one step immunochromatographic test for the rapid, qualitative detection of THC and cocaine.
- 6. Intended Use: LifeSign® Home Drug Test (THC/COC) is designed for the qualitative detection of THC metabolite, 11-nor-A-THC-9-carboxylic acid, at the cutoff of 50 ng/mL and 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: LifeSign® Home Drug Test (THC/COC) is substantially equivalent to-k990786; Status DS™ DOA10. Both products use the same assay principle and immunochromatographic assay to detect THC and cocaine qualitatively. The detection cutoff levels are the same. The tests demonstrate 100 % correlation when 100 specimens (50 negative and 50 positive) for each drug were compared respectively. The difference is that LifeSign® Home Drug Test (THC/COC) detects THC and cocaine only, while Status DS™ DOA10 detects six other drugs of abuse in addition to THC and cocaine. The two devices use the same antibody for THC test, but different antibody for COC test.
- 8. Consumer Study: In a consumer study, LifeSign® Home Drug Test (THC/COC) showed over 96% overall accuracy.

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Conclusion: The device is substantially equivalent to the legally marketed device k990786,

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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: 14067

- 1. Date of Summary: Nov.30, 2001
Princeton BioMeditech Corperation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE [phone] FAX [phone]

Contact Person: Jemo Kang

- 3. Device Name
Trade Names: Stick: Status Stik™ THC/COC, AccuSign®Stik THC/COC, AccuStik™ THC/COC Card: AccuSign® THC/COC, Status DSTM THC/COC Strip: AccuStrip™ THC/COC Common or Usual Name: Immunoassay for detection of THC and cocaine in

human urine

Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DIO for Enzyme Immunoassay)

- 4. Identification of legally marketed device to which claims equivalence: k990786: Status DS ™ DOA10(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) =
- Stik™ Status 5. Device Description: THC/COC is simple one sten immunochromatographic test for the rapid, qualitative detection of THC and cocaine.
- 6. Intended Use: Status Stik™ THC/COC is designed for the qualitative detection of THC metabolite, 11-nor-A2-THC-9-carboxylic acid, at the cutoff of 50 ng/mL and 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™ THC/COC is substantially equivalent to k990786; Status DS™ DOA10. Both products use the same assay principle and immunochromatographic assay to detect THC and cocaine qualitatively. The detection cutoff levels are the same. The tests demonstrate 100 % correlation when 100 specimens (50 negative and 50 positive) for each drug were compared respectively. The difference is that Status Stik™ THC/COC detects THC and cocaine only, while Status DS™ DOA10 detects six other drugs of abuse in addition to THC and cocaine. The two devices use the same antibody for THC test, but different antibody for COC test.
- 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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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k014067

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

JUN 1 0 2002

Dear Dr. Kang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced abo and have determined the device is substantially equivalent (for the indications for use stated in the enclosur to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactmen 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 registrati 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 CC 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 made a determination that your device complies with other requirements of the Act or any Federal statutes 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFF 1000-1050.

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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 ' 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

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Page · of

510(k) Number (if known): Ko I Hole J

Device Name: LifeSign®Home Drug Test, Marijuana & Cocaine(THC/COC)

Indications For Use:

Immunoassay for the qualitative detection of THC metabolite, 11-nor-A-THC-9carboxylic acid, at the cut-off of 50 ng/mL and cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use

Pan

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014067

(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)

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Page **_ of _**

Koluob7 510(k) Number (if known): --

Device Name: Stick: Status Stik™ THC/COC, AccuSign®Stik THC/COC, AccuStik™ THC/COC Card: AccuSign® THC/COC, Status DS™ THC/COC Strip: AccuStrip™ THC/COC

Indications For Use:

Immunoassay for the qualitative detection of THC metabolite, 11-nor-A-THC-9carboxylic acid, at the cut-off of 50 ng/mL and cocaine metabolite, benzoylecgonine, at the cut-off of 300 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use

Han Cooger

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014067

(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)