LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC

K014066 · Princeton BioMeditech Corp. · LDJ · Jun 10, 2002 · Clinical Toxicology

Device Facts

• Record ID: K014066
• Device Name: LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
• Applicant: Princeton BioMeditech Corp.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Status Stik™ THC is designed for the qualitative detection of THC metabolite, 11-nor-A -THC-9-carboxylic acid, at the cutoff of 50 ng/mL in human urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use. LifeSign®Home Drug Test (THC)is designed for the qualitative detection of THC metabolite. 11-nor-A-THC-9-carboxylic acid. at the cutoff of 50 ng/mL in urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use.

Device Story

Rapid, one-step immunochromatographic test for qualitative detection of THC metabolite in human urine; utilizes specific antibodies to detect 11-nor-A9-THC-9-carboxylic acid at 50 ng/mL cutoff. Device formats include sticks, cards, and strips. Used by healthcare professionals or consumers (home use) to screen for drug abuse. Visual readout provided by test line presence/absence; assists in clinical or personal screening decisions. Benefits include rapid, point-of-care identification of THC presence.

Clinical Evidence

Bench testing demonstrated 100% correlation with predicate device using 100 specimens (50 positive, 50 negative). Consumer study for LifeSign® Home Drug Test (THC) reported over 95% overall accuracy.

Technological Characteristics

Immunochromatographic assay; lateral flow format (stick, card, or strip). Uses specific antibodies for THC metabolite detection. Qualitative visual readout. No electronic components or external energy source required.

Indications for Use

Indicated for qualitative detection of THC metabolite (11-nor-A9-THC-9-carboxylic acid) in human urine at a 50 ng/mL cutoff. Intended for screening drugs of abuse in professional settings (prescription use) or home settings (OTC use).

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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) Summarv

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:

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 Contact Person: Jemo Kang

3. Device Name: Trade Names: Stick Device: Status Stik™ THC, AccuSign® Stik THC, AccuStik™ THC Card Device: AccuSign® THC, Status DS™ THC Strip Test: AccuStrip™ THC Common or Usual Name: Immunoassay for detection of THC in human urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE 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: Status Stik™ THC is simple one step immunochromatographic test for the rapid, qualitative detection of THC.
- 6. Intended Use: Status Stik" THC is designed for the qualitative detection of THC metabolite, 11-nor-A -THC-9-carboxylic acid, at the cutoff of 50 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 is substantially equivalent to k990786; Status DS "DOA10. Both products use the same assay principle and immunochromatographic assay, and the same antibody to detect THC 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 difference is that Status Stik" THC detects THC only, while Status DS DOA10 detects nine other drugs of abuse in addition to THC.
- 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) Summarv

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:

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: LifeSign®Home Drug Test (THC) Common or Usual Name: Immunoassay for detection of THC in human urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE 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)
- LifeSign®Home Drug Test (THC) is simple one 5. Device Description: sten immunochromatographic test for the rapid, qualitative detection of THC.
- 6. Intended Use: LifeSign®Home Drug Test (THC)is designed for the qualitative detection of THC metabolite. 11-nor-A-THC-9-carboxylic acid. at the cutoff of 50 ng/mL in human urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use.
- 7. Substantial Equivalence: LifeSign®Home Drug Test (THC) is substantially equivalent to k990786; Status DS DOA10. Both products use the same assay principle and immunochromatographic assay, and the same antibody to detect THC 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 difference is that LifeSign Home Drug Test (THC) detects THC only, while Status DS "DOA10 detects nine other drugs of abuse in addition to THC.
- 8. Consumer Study: In a consumer study, LifeSign® Home Drug Test (THC) showed over 95% 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JUN 1 0 2002

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

Re: k014066

> Trade/Device Name: LifeSign®Home Drug Test (THC) Status Stik™ THC. AccuSign®Stik THC. AccuStik™ THC. AccuSign® THC, Status DSTM THC, Strip: AccuStrip™ THC Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ 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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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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|---|------------------|
| | |

510(k) Number (if known): _ | ص ب ب 06

Device Name: __ LifeSign Home Drug Test (THC)

Indications For Use:

Immunoassay for the qualitative detection of THC metabolite, 11-nor-A2-THC-9-carboxylic acid, at the cut-off of 50 ng/mL in urine to assist in screening of drugs of abuse samples at home. For In vitro Diagnostic Use

(Division S-Off)
Division.mical Laboratory Devices
510(k) Number Koi14066

(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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510(k) Number (if known): k014066

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

510(k) Number "

Indications For Use:

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

Dan Cooper

(Division Sign-Off)
Division of Clinical Laboratory/Devices

(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)