(227 days)
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No
The description focuses on a chemical-based urine screening test and a subsequent lab confirmation service, with no mention of AI/ML or related concepts.
No
The device is a drug screening test used to detect the presence of drugs, not to treat or alleviate a disease or condition.
Yes
Explanation: The device is intended to "detect and identify the presence of drugs within the body using a urine sample," which is a diagnostic function. It screens for the presence of specific substances (COC, THC, NOR, AMP, PCPC) to provide information about a person's health status related to drug use.
No
The device description clearly states it is an "at home drug screening test" that uses a "urine sample" to detect drugs. This indicates the device includes physical components for sample collection and analysis, not just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "preliminary screen to detect and identify the presence of drugs within the body using a urine sample." This involves testing a sample taken from the body (in vitro) to provide diagnostic information about the presence of substances.
- Sample Type: The device uses a "urine sample," which is a biological specimen taken from the body.
- Purpose: The purpose is to "detect and identify the presence of drugs," which is a diagnostic function.
The fact that it's an "at home" test and a "preliminary screen" that requires confirmation doesn't change its classification as an IVD. IVDs can be used in various settings (including home) and can provide preliminary or definitive results.
N/A
Intended Use / Indications for Use
DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).
DrugStop is the first step in a two step testing process. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample NUST be sent to our reference lab for confirmation at no additional cost to the customer. Home drug tests are not as accurate as lab tests and any PRELIMINARY results NUST BE CONFIRMED before any action is taken against the person being tested.
Product codes
MVO
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
at home
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.
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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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N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The bird is facing to the left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 0 1999
Mr. Charles W. Gill Director of Research & Development Texas Immunology, Inc. 12524 FM 3226 Tyler, Texas 75707
Re: K991465 Trade Name: DrugStop™ Regulatory Class: II Product Code: MVO Dated: September 29, 1999 Received: October 1, 1999
Dear Mr. Gill:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 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 Sutman
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
K991465 510(k) Number (if known):
Device Name: DRUG STOP
Indications For Use:
DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).
DrugStop is the first step in a two step testing process. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample NUST be sent to our reference lab for confirmation at no additional cost to the customer. Home drug tests are not as accurate as lab tests and any PRELIMINARY results NUST BE CONFIRMED before any action is taken against the person being tested.
Ron Coofa
(Division Sign-Off)
Division of Clinical Laboratory Devices
vision 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)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)