LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET

K014192 · Princeton BioMeditech Corp. · MVO · May 23, 2002 · TX

Device Facts

• Record ID: K014192
• Device Name: LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
• Applicant: Princeton BioMeditech Corp.
• Product Code: MVO · TX
• Decision Date: May 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

Life Sign® Home Drug Test (MET) is designed for the qualitative detection of methamphetamine at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home or work place. For In vitro Diagnostic Use. Status Stik™ MET is designed for the qualitative detection of methamphetamine at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic, Prescription Use.

Device Story

One-step immunochromatographic test for qualitative detection of methamphetamine in urine; utilizes lateral flow immunoassay principle; provides visual qualitative result; intended for home, workplace, or professional screening; detects methamphetamine at 1000 ng/mL cutoff; assists healthcare providers or consumers in identifying potential drug use; results interpreted visually by user.

Clinical Evidence

Bench testing only. Comparison of 94 specimens (50 negative, 44 positive) demonstrated 100% correlation with the predicate device. A consumer study reported over 96% overall accuracy.

Technological Characteristics

Immunochromatographic lateral flow assay; qualitative visual readout; urine specimen; 1000 ng/mL cutoff; non-automated; no electronic components or software.

Indications for Use

Indicated for the qualitative detection of methamphetamine in urine at a 1000 ng/mL cutoff for screening drugs of abuse in home, workplace, or professional settings.

Predicate Devices

• Status DS™ DOA 10 (K990786)

Submission Summary (Full Text)

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#### MAY 2 3 2002

### 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: K014 | 92

1. Date of Summary: Dec. 13. 2001

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

Contact Person: Jemo Kang, Ph.D.

- 3. Device Name: Trade Names: Life Sign® Home Drug Test(MET) Common or Usual Name: Immunoassay for detection of methamphetamine in urine Classification Name: Drugs of Abuse Analysis Systems, Toxicology
(91LAG for HPLC)

- 4. Identification of legally marketed device to which claims equivalence: k990786; Status DS™ DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
- 5. Device Description: Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
- 6. Intended Use:Life Sign® Home Drug Test (MET) is designed for the qualitative detection of methamphetamine at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples at home or work place. For In vitro Diagnostic Use
- 7. Substantial Equivalence: Life Sign® Home Drug Test (MET) is substantially equivalent to the k990786; Status DS ** DOA 10. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The detection cutoff level is the same. The tests demonstrate 100 % correlation when 94 specimens (50 negative and 44 positive) were compared. The difference is that Life Sign® Home Drug Test (MET) detects methamphetamine only, while Status DS " DOA 10 detects nine other drugs of abuse in addition to methamphetamine.
- 8. Consumer Study: In a consumer study, LifeSign® Home Drug Test (MET) showed over 96% overall accuracy.
- Conclusion: The device is substantially equivalent to a legally marketed device k990786, Status DS™DOA 10 (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: _ k O | 4192

- 1. Date of Summary: Dec. 13, 2001
Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE [phone] FAX

Contact Person: Jemo Kang, Ph.D.

- 3. Device Name: Trade Names: Stick Device: Status Stik" MET, AccuSign® Stik MET, AccuStik"" MET
Card Device: AccuSign® MET, Status DS " MET

Strip Test: AccuStrip "" MET

Common or Usual Name: Immunoassay for detection of methamphetamine in

urine

Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91LAG for HPLC)

- 4. Identification of legally marketed device to which claims equivalence: k990786; Status DS™ DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
- 5. Device Description: Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
- 6. Intended Use: Status Stik" MET is designed for the qualitative detection of methamphetamme at the cutoff of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic, Prescription Use.
- 7. Substantial Equivalence: Status Stik" MET is substantially equivalent to the k990786; Status DS™ DOA 10. Both products use the same assay principle and immunochromatographic assay to detect methamphetamine qualitatively. The detection cutoff level is the same. The tests demonstrate 100 % correlation when 94 specimens (50 negative and 44 positive) were compared. The difference is that Status Stik™ MET detects methamphetamine only, while Status DS™ DOA 10 detects nine other drugs of abuse in addition to methamphetamine.

Conclusion: The device is substantially equivalent to a legally marketed device k990786, Status DS™ DOA 10 (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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

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: k014192

> Trade/Device Name: LifeSign®Home Drug Test (MET) Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET, AccuSign® MET, Status DSTM MET, Strip: AccuStrip™ MET Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: MVO; DJC Dated: April 9, 2002 Received: April 10, 2002

MAY 2 3 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 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/cdrb/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):

Device Name: LifeSign®Home Drug Test ( MET)

Indications For Use:

Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 for ng/mL in urine to assist in screening of drugs of abuse samples at home and work place. For In vitro Diagnostic Use

Page

Jean Cooger
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014192

(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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#### K 814197 510(k) Number (if known):

Device Name: Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET, AccuSign® MET, Status DSTM MET, Strip: AccuStrip™ MET

Indications For Use:

Immunoassay for the qualitative detection of methamphetamine at the cut-off of 1000 ng/mL in urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use

Trade Names for each format

Stick: Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET Card: AccuSign® MET, Status DSTM MET Strip: AccuStrip™ MET

Sean Coogler

(Division Sign Off)
Division of ...nical Laboratory r
510(k) Number K014192

(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)