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 at home and work place. For In vitro Diagnostic 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

Device Description

Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.

Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided documents describe two variations of the device:

Life Sign® Home Drug Test (MET): Intended for home or workplace use (Over-The-Counter).
Status Stik™ MET, AccuSign®Stik MET, AccuStik™ MET, AccuSign® MET, Status DSTM MET, AccuStrip™ MET (collectively referred to as "Professional Use Devices"): Intended for professional/prescription use.

Both devices are for the qualitative detection of methamphetamine in urine at a cutoff of 1000 ng/mL.

Acceptance Criteria	Reported Device Performance	Comments
Qualitative Detection of Methamphetamine in Urine at 1000 ng/mL Cutoff	The devices demonstrate 100% correlation with the predicate device (K990786; Status DS™ DOA 10) in detecting methamphetamine qualitatively at the 1000 ng/mL cutoff.	This is the primary functional acceptance criterion. The 100% correlation is a strong indicator of meeting this.
Substantial Equivalence to Predicate Device (K990786; Status DS™ DOA 10)	The devices "are 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."	This is the overarching regulatory acceptance criterion for 510(k) clearance. The provided text claims and concludes substantial equivalence.
Overall Accuracy (for Consumer Study / OTC version)	LifeSign® Home Drug Test (MET) showed over 96% overall accuracy in a consumer study.	This criterion is specific to the Life Sign® Home Drug Test (MET), indicating its performance in the hands of intended users (consumers).

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: 94 specimens (50 negative and 44 positive) were used for comparison between the new device and the predicate device.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective comparison as it evaluates the new device against already available specimens.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the given text. The "ground truth" seems to be established by comparison to a legally marketed predicate device (Status DS™ DOA 10) rather than by independent expert assessment of each sample.
Adjudication Method for the Test Set:
- This information is not provided. The method mentioned is a direct comparison to the predicate device's results.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The study focused on a 100% correlation between the new device and a predicate device.
- The "consumer study" for the LifeSign® Home Drug Test (MET) that showed "over 96% overall accuracy" might involve multiple lay users, but it's not described as a formal MRMC comparative effectiveness study demonstrating improvement with AI vs. without AI. The device described is a rapid immunoassay, not an AI-powered diagnostic system.
Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, a standalone performance was done. The 100% correlation study between the new device and the predicate device is a standalone performance evaluation of the device itself.
- For the professional use versions, the device is intended for clinical laboratory or professional settings, implying human interpretation of the result, but the 100% correlation study is about the device's inherent detection capability.
- For the home use version, the "consumer study" also evaluates the standalone performance, likely including the human-in-the-loop (the consumer performing and interpreting the test). However, it's not an AI algorithm.
Type of Ground Truth Used:
- The primary ground truth for the comparison study was the results obtained from a legally marketed predicate device (K990786; Status DS™ DOA 10).
- For the 94 specimens, the predicate device results likely served as the reference standard to determine if the 50 negative and 44 positive classifications were truly negative and positive, respectively. This implies the predicate device's performance was accepted as truth.
Sample Size for the Training Set:
- This information is not provided. The description focuses on a comparison study/test set, not the development or training of the immunoassay itself. As this is a rapid immunoassay (not an AI/machine learning model), the concept of a "training set" in the context of machine learning does not apply directly. The development would involve analytical validation rather than machine learning training.
How the Ground Truth for the Training Set Was Established:
- Not applicable as no training set (in the machine learning sense) is described. The "ground truth" reference during the immunoassay development would typically involve analytical methods (e.g., GC/MS, HPLC) to confirm the presence and concentration of the target analyte in spiked or characterized samples.

Summary

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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

Date of Summary: Dec. 13. 2001

Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 732-274-1010 FAX

Contact Person: Jemo Kang, Ph.D.

1. 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)
1. Identification of legally marketed device to which claims equivalence: K990786; Status DS™ DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
1. Device Description: Life Sign® Home Drug Test (MET) is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
1. 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
1. 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.
1. 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 732-274-1000 732-274-1010 FAX

Contact Person: Jemo Kang, Ph.D.

1. 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)

1. Identification of legally marketed device to which claims equivalence: K990786; Status DS™ DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
1. Device Description: Status Stik™ MET is simple one step immunochromatographic test for the rapid, qualitative detection of methamphetamine.
1. 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.
1. 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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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Over The Counter Use: X

(Optional Format 1-2-96)

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Page

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)

Over The Counter Use:

(Optional Format 1-2-96)

Regulation Number and Section

N/A