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K Number
K014066
Device Name
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
2002-06-10

(182 days)

Product Code
LDJ
Regulation Number
862.3870
Type
Traditional
Panel
Toxicology
Reference & Predicate Devices
k990786
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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
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

Device Description

Status Stik™ THC is simple one step immunochromatographic test for the rapid, qualitative detection of THC.
LifeSign®Home Drug Test (THC) is simple one sten immunochromatographic test for the rapid, qualitative detection of THC.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the provided devices, based on the input text:

Acceptance Criteria and Device Performance

The provided text describes two devices, "Status Stik™ THC" (and its variants) and "LifeSign® Home Drug Test (THC)," both intended for the qualitative detection of THC. The studies conducted prove their substantial equivalence to a predicate device, K990786 Status DS™ DOA10.

Acceptance Criteria for Substantial Equivalence:

The primary acceptance criterion mentioned across both submissions is 100% correlation with the legally marketed predicate device (K990786 Status DS™ DOA10) when tested against a specific set of specimens.

Acceptance CriteriaReported Device Performance (Status Stik™ THC / LifeSign® Home Drug Test (THC))
100% correlation with predicate device100% correlation
Detection cutoff of 50 ng/mL in human urineSame cutoff of 50 ng/mL
Same assay principleUses the same assay principle
Same immunochromatographic assayUses the same immunochromatographic assay
Same antibody to detect THC metaboliteUses the same antibody

For the "LifeSign® Home Drug Test (THC)" specifically, an additional acceptance criterion related to consumer use was evaluated:

Acceptance CriteriaReported Device Performance (LifeSign® Home Drug Test (THC))
Over 95% overall accuracy in a consumer studyShowed over 95% overall accuracy

Study Details for Substantial Equivalence

2. Sample size used for the test set and the data provenance:

  • Sample Size: 100 specimens (50 negative and 50 positive for THC).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in vitro diagnostic device, the specimens would likely be human urine samples. The nature of the comparison to a legally marketed device suggests a retrospective analysis of previously collected or prepared samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • This information is not provided in the summaries. The ground truth for the 100 specimens would have been established by a reference method to categorize them as "positive" or "negative" for THC at the specified cutoff.

4. Adjudication method for the test set:

  • This information is not provided in the summaries. The assessment described is a direct comparison (correlation) between the new device and the predicate device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • No. This type of study (MRMC with AI assistance) is not applicable as the devices described are single-step immunochromatographic tests for direct detection, not AI-powered interpretation tools.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Yes, in essence. The devices described (Status Stik™ THC, LifeSign® Home Drug Test (THC), and their variants) are standalone tests. Their performance is assessed based on the qualitative result (positive/negative line appearance) generated by the device itself. While a human reads the result, the "performance" described (100% correlation) refers to the device's ability to match the predicate, not a human's interpretation proficiency. For the "LifeSign® Home Drug Test (THC)"'s "consumer study," human interpretation is part of the "overall accuracy," but it's still about the device's performance in that context.

7. The type of ground truth used:

  • The ground truth for the 100 specimens used in the equivalence study was established by the predicate device (K990786 Status DS™ DOA10) itself, against which the new devices showed 100% correlation. This implies the predicate device's results were considered the "truth" for this comparison. For the "consumer study" of the LifeSign® Home Drug Test (THC), the "overall accuracy" would have been determined by comparing the consumer's test result to an independent, more definitive laboratory method (e.g., GC/MS or another high-accuracy lab-based immunoassay).

8. The sample size for the training set:

  • This information is not applicable/provided. These are immunoassay devices, not machine learning algorithms that typically require a distinct "training set." The development of the assay (e.g., antibody selection, assay conditions) would have involved extensive R&D, but this is distinct from a "training set" in the AI/ML context.

9. How the ground truth for the training set was established:

  • This information is not applicable/provided for the reasons stated above.

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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 732-274-1000 732-274-1010 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)

    1. Identification of legally marketed device to which claims equivalence: K990786 Status DS™DOA10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
    1. Device Description: Status Stik™ THC is simple one step immunochromatographic test for the rapid, qualitative detection of THC.
    1. 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.
    1. 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
    1. Submitted by: Princeton BioMeditech Corperation 4242 U.S. Route 1. Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang
  1. 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)
    1. 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.
    1. 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.
    1. 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.
    1. 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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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 ' 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/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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TくA11

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)

§ 862.3870 Cannabinoid test system.

(a)
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 includedelta -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.(b)
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).