(383 days)
Not Found
No
The device description clearly states it uses a "rapid chromatographic immunoassay," which is a chemical-based detection method, not AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an educational screening test for drug detection and does not provide therapeutic treatment or diagnosis.
Yes.
The device is intended for consumer use to provide information regarding the presence or absence of four drugs, serving as the "first step in a two step process" for screening. This aligns with the definition of a diagnostic device, which is used to identify the presence of a condition or substance.
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 that the device is for the "rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine." This involves testing a sample taken from the human body (urine) outside of the body to gain information about a person's health status (presence of drugs).
- Device Description: The description details a "rapid chromatographic immunoassay" that "qualitatively measures the presence or absence of marijuana, cocaine, morphine/opiates, methamphetamine and/or their metabolites in urine." This is a common method used in IVD tests.
- Predicate Devices: The listed predicate devices (K972425 Applied Biotech SureStep™ Drug Screen Multi Test; Phamatech QuickScreen™ At Home Drug Test) are also IVD devices for drug screening in urine. This further supports the classification of this device as an IVD.
While the intended user is a consumer and the purpose is educational screening, the core function of the device is to perform a diagnostic test on a biological sample in vitro (outside the body). This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The First Check® Home Drug Fest Panel 4 is an educational sereening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/mL respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the four drugs concorned parchib, was not information is beneficial to consumer offorts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
Product codes (comma separated list FDA assigned to the subject device)
LAF, DIO, DJG, LDJ
Device Description
The First Check® Home Drug Test Panel 4, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, morphine/opiates, methamphetamine and/or their 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. The cut-off concentration for COC is 300ng/mL. The cut-off concentration for OPI is 300ng/mL. The cut-off concentration for MET is 1,000ng/mL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Consumer use / At home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).
0
NOV 2 9 2000
Image /page/0/Picture/3 description: The image shows a pattern of alternating dark and light triangles. The dark triangles are arranged in a row, and the light triangles are positioned between them. The pattern is repeated across the image, creating a visually interesting design. The contrast between the dark and light triangles makes the pattern stand out.
Section D 510(k) Summary 21 C.F.R. § 807.92
- Submitter: I.
- Name: Worldwide Medical Corporation A.
- Address: 199 Technology Drive, Suite 150, Irvine, California B. 92618
- C. Phone and Fax Numbers: Phone: 949/727-0711 949/727-0602 Fax:
- Contact Person: H. Thad Morris D.
- Date of Preparation of this Summary: November 8, 1999 II.
- Trade Name: First Check® Home Drug Test Panel 4 III.
- Common Name: At home drugs of abuse rapid screening test for IV. marijuana, cocaine, morphine/opiates and methamphetamine in urine.
- Classification Name: Immunoassay for the qualitative detection of drugs V. of abuse in urine.
- VI. The Marketed Products to Which Equivalence is Claimed: The First Check® Home Drug Test Panel 4 that is the subject of this submission is identical to the Applied Biotech SureStep™ Drug Screen Multi 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.
- VII. Statement of Intended Use Compared to Other Products: The intended use of the First Check® Home Drug Test Panel 4 is substantially equivalent to the listed products; it is a preliminary, rapid screening test for the detection of marijuana, cocaine, morphine/opiates and methamphetamine and/or their 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 these four drugs and/or their metabolites in a urine sample. Information regarding the second step, confirmatory testing, is provided.
199 Technology Drive Suite 150 Irvine, CA 92618 949-727-0711 800-788-5716 949-727-0602 .wwwmed.com
Stock symhol: WMED
1
Image /page/1/Picture/1 description: The image is a black and white photograph of a patterned surface. The pattern appears to be a repeating design of dark shapes against a lighter background. The shapes are somewhat geometric, possibly triangles or similar angular forms, arranged in a grid-like fashion. The overall effect is a textured or tessellated appearance, with the contrast between the dark shapes and the light background creating a visually interesting pattern.
- Discussion of Technological Characteristics: The First Check® Home VIII. Drug Test Panel 4, like many commercially available drug screening tests, qualitatively measures the presence or absence of marijuana, cocaine, morphine/opiates, methamphetamine and/or their 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. The cut-off concentration for COC is 300ng/mL. The cut-off concentration for OPI is 300ng/mL. The cut-off concentration for MET is 1,000ng/mL.
- IX. Safety and Effectiveness: Because the First Check® Home Drug Test Panel 4 is identical to the Applied Biotech SureStep™ Drug Screen Multi Test that is legally marketed under K972425, 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 the listed drugs and their metabolites. Because the labeling of the First Check® Home Drug Test Panel 4 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 in which the product line has been purchased by the general public and used in quantities exceeding 200,000 tests, it is concluded that the product can be used effectively by the lay user.
199 Technology Drive Suite 150 Irvine, CA 92618 949-727-0711 800-788-5716 949-727-0602 .rw.wwmed.com Stock symbol: WMED
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
NOV 2 9 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Worldwide Medical Corporation c/o Mr. Larry R. Pilot McKenna & Cueno, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108
K993852 Re:
Trade Name: First Check® Home Drug Test Panel 4 Regulatory Class: II Product Code: LAF, DIO, DJG, LDJ Dated: October 30, 2000 Received: October 30, 2000
Dear Mr. Pilot:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have toviewed your betermined the equivalent (for the indications for use above and we nave determinent in marketed predicate devices marketed in interstate commerce surved in the energians, to renactment 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 Cosments of the Act. The general controls provisions of the Act include requirements for annual provisions of the Fee. "The generod 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 (1 remance ripproval), 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 (QS) 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 may with the GMP regulation may result in regulatory action. In addition, FDA may publish compry with the CHI reoncerning 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.
3
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 partited 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/cdrl/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
4
SECTION A
Page 1 of 1
510(k) Number (if known): _ 1 993852
Device Name: First Check® Home Drug Test Panel 4
Indications for Use:
- The First Check® Home Drug Fest Panel 4 is an educational sereening test for the rapid detection of marijuana, cocaine, morphine/opiates, methamphetamine and for their metabolites in human urine at cut-off levels of 50ng/mL, 300ng/mL, 300ng/mL and 1,000ng/mL respectively. The test is intended for consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the four drugs concorned parchib, was not information is beneficial to consumer offorts to comply with applicable laws and/or societal expectations. Information regarding second step confirmatory testing is provided.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
$_$ over the-counter DS
(Optional Format 3-10-98)
199 Technology Drive Suite 150 Irvine, CA 92618 949-727-0711 800-788-5716 949-727-0602 .wwwmed.com Stock symbol: WMED