(86 days)
Not Found
Not Found
No
The description details a standard immunochromatographic assay, which is a chemical reaction-based test, with no mention of AI or ML.
No.
The device is a qualitative drug test designed to determine the presence of drugs in a urine sample; it does not treat or alleviate any condition, which is the purpose of a therapeutic device.
Yes
The device is designed for the qualitative determination of drugs and their metabolites in human urine, providing information about the presence or absence of these substances, which is a diagnostic function.
No
The device description explicitly states it is an "immunochromatographic based one step in vitro test," which is a hardware-based test strip or similar physical device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "in vitro test": The device description explicitly states it is an "in vitro test". "In vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- "qualitative determination of five drugs of abuse and their metabolites in human urine": The intended use clearly states that the test analyzes a biological sample (human urine) to determine the presence of specific substances (drugs and their metabolites). This is a core characteristic of an IVD.
- "immunochromatographic competitive assay": This describes a common type of assay used in IVDs to detect specific substances in a sample.
- "used to screen human urine": This further reinforces that the test is analyzing a biological sample.
The fact that it is a "Home Drug Test" and intended for "home" use does not change its classification as an IVD. IVDs can be designed for use in various settings, including at home.
N/A
Intended Use / Indications for Use
The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
Product codes (comma separated list FDA assigned to the subject device)
MVO, LDJ, DIO, DJC, DPK, LCM
Device Description
The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Not Found
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
N/A
0
FEB 0 7 2002
510(k) Summary
KU13778
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:
- Date of summary: November 8, 2001
- aLATEX Scientific Inc. 2. Submitted by: 6355 Westheimer Rd. Suite 105 Houston TX 77057
Peace of Mind Home Drug Test 3. Device Name:
-
Device Classification: Class II, Panel 91 Toxicology
-
Device description: The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
-
Intended Use: The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
- Substantial Equivalence: The Peace of Mind Home Drug Test is substantially equivalent to several other professional and over the counter immunoassay Drugs of Abuse Tests, such as Phamatec QuickScreen™ At Home Test and the Drug Stop Test. These home drug tests are the first of a two-step process to detect the presence or absence of drugs of abuse in human urine and require consumers to confirm possible positive results with GC/MS.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract image of an eagle. The eagle is depicted with three stylized wing strokes and a curved body, symbolizing the department's mission related to health and human welfare. The logo is simple and monochromatic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 0 7 2002
aLATEX Scientific Inc. c/o Ms. Janis Freestone Director, Regulatory Affairs Advantage Diagnostics Corporation, Ltd. 1201 Douglas Avenue Redwood City, CA 94063
K013778 Re:
Trade/Device Name: Peace of Mind Home Drug Test Regulation Number: 21 CFR 862.3870; 21 CFR 862.3250; 21CFR 862.3610; 21 CFR 862.3640 Regulation Name: Cannabinoid test system; Cocaine and cocaine metabolite test system; Methamphetamine test system; Morphine test system Regulatory Class: Class II; Class II; Class II; Class II; Class II Product Code: MVO; LDJ; DIO; DJC; DPK; LCM Dated: November 12, 2001 Received: November 13, 2001
Dear Ms. Freestone:
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.
2
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I hils letter will anow your of substantial equivalence of your device to a legally marketed nothication. The I Dri Intention 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 1 II you desire specific active actives), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (301) 594-4500. Traditionally) and eat (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 mioritation on your respections.
Manufacturers International Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrfb/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
3
K013778 510k Number:
Device Name: Peace of Mind Home Drug Test
Indications for Use:
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
Sian Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013778
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Image /page/3/Picture/11 description: The image shows the phrase "Over the counter use" with a symbol next to it. The symbol is a line with an X over it. This symbol is commonly used to indicate that something is not allowed or should not be done. The text and symbol together likely indicate that the product is not intended for over-the-counter use.