(238 days)
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No
The device description clearly states it uses a chromatographic immunoassay, which is a traditional chemical detection method, and there is no mention of AI or ML in the provided text.
No.
The device is described as an educational screening test for the rapid detection of THC, not for treating any medical condition or disease.
Yes
Explanation: The device is an "educational screening test for the rapid detection of THC (and its metabolites) in human urine," which gathers information about a person's health status (presence of THC and its metabolites). This aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "rapid chromatographic immunoassay" which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the rapid detection of THC (and its metabolites) in human urine. This is a biological sample taken from the body and tested outside of the body, which is the definition of "in vitro".
- Device Description: The description details a "rapid chromatographic immunoassay" that measures the presence or absence of THC and its metabolites in urine. This further confirms the in vitro nature of the test.
- Predicate Devices: The listed predicate devices (K960744 and Phamatech QuickScreen™ At Home Drug Test) are also home drug tests that analyze urine, which are classified as IVDs.
While the intended use mentions it's an "educational screening test" and the first step in a two-step process, the core function of analyzing a biological sample (urine) for the presence of a substance (THC) outside of the body firmly places it in the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The First Check Home Drug Test (THC) is an educational screening test for the rapid detection of THC (and its metabolites) in human urine at a cut off for the rapid dececeion of the (antended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned a two seep process to provious concerning the presence of THC (and its parents, with information obliozing is beneficial to consumer metabolices) in a arine baspeable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Product codes (comma separated list FDA assigned to the subject device)
LDJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
consumer
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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JUN 2 3 2000
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Section D 510(k) Summary 21 C.F.R. § 807.92
- I. Submitter:
- Name: Worldwide Medical Corporation A.
- Address:199 Technology Drive, Suite 150, Irvine, California B. 92618
- Phone and Fax Numbers: Phone: 949/727-0711 C. Fax: 949/727-0602
- Contact Person: H. Thad Morris D.
- Date of Preparation of this Summary: September 29, 1999 II.
- III. Trade Name: First Check® Home Drug Test (THC)
- Common Name: At home drugs of abuse rapid screening test for THC in IV. urine
- Classification Name: Immunoassay for the qualitative detection of THC in V. urine
- The Marketed Products to Which Equivalence is Claimed: The First VI. Check® Home Drug Test (THC) that is the subject of this submission is identical to the Applied Biotech SureStep™ Drug Screen THC Test in terms of intended use, product design, performance characteristics, materials of construction, and manufacturing process. It is also substantially equivalent to the Phamatech QuickScreen™ At Home Drug Test and other commercially available drug screening tests which qualitatively measure the presence of target drugs or metabolites by visual color one step immunoassay technology.
- Statement of Intended Use Compared to Other Products: The intended use VII. of the First Check® Home Drug Test (THC) is substantially equivalent to the listed products; it is a preliminary, rapid screening test for the detection of THC and its metabolites in urine. This product is intended to be the first step in a two step process to provide consumers, including concerned parents. with information regarding the presence or absence of THC (and its metabolites) in a urine sample. Information regarding the second step, confirmatory testing, is provided.
199 Technology Drive Suite 150 Irvine, CA 92618 ·49-727-0711 800-788-5716 Fax: 949-727-0602 www.wwmed.com
Stock symbo : WMED
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- Discussion of Technological Characteristics: The First Check® Home VIII. Drug Test (THC), like many commercially available drug screening tests, qualitatively measures the presence or absence of THC and its metabolites in urine using a one step rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug/antibody complexes. The cut-off concentration for THC is 50ng/mL.
- IX. Safety and Effectiveness: Because the First Check® Home Drug Test (THC) is identical to the Applied Biotech SureStep™ Drug Screen THC test that is legally marketed under K960744, and because no special skills, training, education, or licensure are required to transfer a dropper level of urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of THC and its metabolites. Because the labeling of the First Check® Home Drug Test (THC) is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the Phamatech QuickScreen™ At Home Drug Test, and there have been no reports of consumer inability to follow instructions or interpret results during the twenty-four months the product has been purchased by the general public and used in quantities exceeding 87,000 tests, it is concluded that the product can be used effectively by the lay user.
199 Technology D. ... : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : - 2 ( 2 0 2 ) 3 Fer 949 721 Coll www.wwmed.com Stock symbol WMED
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 3 2000
Worldwide Medical Corporation c/o Mr. Larry R. Pilot McKenna & Cueno, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108
Re: K993663
Trade Name: First Check® Home Drug Test (THC) Regulatory Class: II Product Code: LDJ Dated: May 23, 2000 Received: May 23, 2000
Dear Mr. Pilot:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 (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 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 Gutman
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 I of 1
510(k) Number (if known):_K993663
First Check Home Drug Test (THC) Device Name:
Indications For Use:
The First Check Home Drug Test (THC) is an educational screening test for the rapid detection of THC (and its metabolites) in human urine at a cut off for the rapid dececeion of the (antended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned a two seep process to provious concerning the presence of THC (and its parents, with information obliozing is beneficial to consumer metabolices) in a arine baspeable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993663
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OVER-The -COUNTA USE
(Optional Format 3-10-98)
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