(182 days)
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 human urine to assist in screening of drugs of abuse samples. For In vitro Diagnostic Use.
LifeSign® Home Drug Test (THC/COC) is simple one step immunochromatographic test for the rapid, qualitative detection of THC and cocaine.
Here's a breakdown of the acceptance criteria and study information for the "LifeSign® Home Drug Test, Marijuana & Cocaine (THC/COC)" and related devices, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative detection of THC metabolite (11-nor-A-THC-9-carboxylic acid) at a cutoff of 50 ng/mL | 100% correlation with predicate device (K990786) |
| Qualitative detection of cocaine metabolite (benzoylecgonine) at a cutoff of 300 ng/mL | 100% correlation with predicate device (K990786) |
| Overall accuracy (for consumer study) | Over 96% overall accuracy |
Study Information
The provided document describes a study primarily for demonstrating substantial equivalence to a predicate device, rather than a de novo clinical trial with extensive acceptance criteria and detailed performance metrics.
-
Sample size used for the test set and the data provenance:
- Sample Size: 100 specimens for each drug (THC and cocaine), consisting of 50 negative and 50 positive samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it compares the device's performance to an already established predicate device's results using collected specimens.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth seems to be implicitly established by the results from the predicate device (K990786) or a reference method used to classify the 100 specimens as positive or negative. No explicit mention of expert readers or their qualifications is provided.
-
Adjudication method for the test set:
- Not applicable/Not specified. The study design described is a direct comparison to a predicate device on pre-classified samples, not one involving multiple human readers needing adjudication.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is an immunochromatographic test, not an AI-powered diagnostic tool requiring human reader assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described (100% correlation and >96% overall accuracy) refers to the standalone performance of the immunochromatographic test device itself. It operates without human-in-the-loop for its direct result interpretation. The "consumer study" indicates its ease of use and accuracy in a home setting, which implies standalone performance by a lay user.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the comparison study appears to be established by the results obtained from the legally marketed predicate device (K990786) or a reference method used to classify the 100 specimens as positive or negative for THC and cocaine. The statement "The tests demonstrate 100 % correlation when 100 specimens (50 negative and 50 positive) for each drug were compared respectively" implies that these 100 specimens had a known status (positive/negative) determined by a reliable method.
-
The sample size for the training set:
- Not applicable/Not specified. This is a rapid immunochromatographic test, not an algorithm that requires a separate training set in the machine learning sense. The device's components (antibodies, reagents) are developed through research and manufacturing processes, but there isn't a "training set" like one would describe for an AI model.
-
How the ground truth for the training set was established:
- Not applicable. (See point 8).
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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
- Date of Summary: Nov.30, 2001
Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010
Contact Person: Jemo Kang
- 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)
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- Identification of legally marketed device to which claims equivalence: K990786; Status DS ™ DOA10(MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)
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- Device Description: LifeSign® Home Drug Test (THC/COC) is simple one step immunochromatographic test for the rapid, qualitative detection of THC and cocaine.
-
- 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.
-
- 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.
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- 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
-
- Date of Summary: Nov.30, 2001
Princeton BioMeditech Corperation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010
- Date of Summary: Nov.30, 2001
Contact Person: Jemo Kang
-
- 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
- Device Name
human urine
Classification Name: Drugs of Abuse Analysis Systems, Toxicology (91DKE, 91DIO for Enzyme Immunoassay)
-
- 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.
-
- 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.
-
- 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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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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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)
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
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.(b)
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).