(97 days)
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Not Found
No
The summary describes a rapid chromatographic immunoassay, which is a chemical test, and does not mention any computational or algorithmic components indicative of AI/ML.
No
The device is a diagnostic test kit for detecting drugs in human urine, not a device used for therapy or treatment.
Yes
The device is a rapid chromatographic immunoassay that qualitatively detects drugs in human urine, providing preliminary test results that require confirmation, which is characteristic of diagnostic devices.
No
The device is described as a "rapid chromatographic immunoassay multi-panel or single drug test," which is a physical test kit that analyzes a urine sample. This description clearly indicates a hardware component is involved.
Based on the provided information, 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 "qualitative detection of one or more of the following drugs... in human urine." This involves testing a sample taken from the human body (in vitro) to gain information about the individual's health or condition (in this case, the presence of drugs).
- Sample Type: The device analyzes "human urine," which is a biological specimen.
- Purpose: The purpose is to provide "information concerning the presence of the above stated drugs or metabolites in a urine sample." This is a diagnostic purpose, even though it's a preliminary test.
The fact that it's intended for over-the-counter use and provides preliminary results that require confirmation does not negate its classification as an IVD. IVDs encompass a wide range of tests, from simple home tests to complex laboratory assays.
N/A
Intended Use / Indications for Use
The IND Drug Home Test is a rapid chromatographic immunoassay multi-panel or single drug test for the qualitative detection of one or more of the following drugs: Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine in human urine. It is intended for overthe-counter use.
Drug Name (Code) Amphetamine (AMP) Methamphetamine (MET) Cocaine (COC) Marijuana (THC) Morphine (MOR)
Cut-off 1000 ng/mL 1000 ng/mL 300 ng/mL 50 ng/mL 300 ng/mL
The test is intended for over-the counter (OTC) use as the first step in a two step process to provide consumers with information concerning the presence of the above stated drugs or metabolites in a urine sample. The test provides only preliminary test results. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS (Gas Chromatography / Mass Spectrometry) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Information regarding confirmatory testing, the second step in the process, is provided in the package labeling.
Product codes (comma separated list FDA assigned to the subject device)
NFW, NGI
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
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter use
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.
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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.
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration
Image /page/0/Picture/2 description: The image contains a black horizontal line. The line is straight and appears to be solid. The background is white. The line is centered vertically in the image.
10903 New Hampshire Avenue Silver Spring, MD 20993
IND Diagnostic, Inc c/o Kai Lou C/o Rai Exe
Regulatory Affairs Department 1629 Fosters Way 1629 Fosters Way
Delta, British Columbia, Canada V3M 6S7
JUL 30 2012
Re:
k 121231
Trade Name: IND Drug Home Multi-Panel Test (2-5) – Cassette and Strip Formats IND Drug Home Multi-Pance Test – Cassette and Strip Formats
IND Amphetamine Home Test – Cassette and Strip Formats IND Amphetamine Home Test – Cassette and Strip Formats
IND Methamphetamine Home Test – Cassette and Strip Formats IND Methamplietannine Tions sees
IND Cocaine Home Test – Cassette and Strip Formats IND Cocaine Home Test - Cassette and Strip Formats
IND Morphine Home Test - Cassette and Strip Formats IND Morphine Home Test – Cassette and Strip Formats
IND Marijuana Home Test – Cassette and Strip Formats
100 Marijuana 10010 – 100 Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulatory Class: Class Class Crass Crass NFW, NGI Dated: July 5, 2012 Received: July 10, 2012
Dear Kai Lou,
Dear III.
We have reviewed your Section 510(k) premarket notification of intent to market the device is a We have reviewed your Section 210(K) premaince is substantially equivalent (for the referenced above and have determined the device Is succedicate devices marketed in
referenced above and have decembre) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to May 28, 1976, the macment with the provisions of
Amendments, or to devices that have been reclassified in accordance with the provisions of
each mercedes that have been reclassified in accondice with accordance while in the premaixel
the Federal Food, Drug, and Cosmetic Act (Act ) that do not require approval of Andreal Food, Drug, and Cosmetic Act (Act) that of not require, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the gen approval application (PMA). You may, therefore, manse the Act include ontrols provisions of the Act. The general collible provisions of the more
requirements for annual registration, listing of devices, good manufacturing practice,
requirement requirements for annual registration, noting on the one of adulteration.
Iabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
ns affectives and the the same additional controls. Existing major regulations If your device is classified (see above) into either class II (Special Conneller)
(PMA), it may be subject to such additional controls. Existing major regulations (CFR), Par (PMA), it may be subject to such additional controls. Exismly institutions of the Solot of Sept.
your device can be found lick forther angouncements concerning your device i (111), which and of the 21, Code of Federal Regulation (Crity), Particle (Cricy, Particle)
In addition, FDA may publish further announcements concerning your device in the Ee Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's issuance of a substantial equires with other requirements
mean that FDA has made a determination that your device with other requires. Press of the Act of Acternination that your device compins with the research agencies.
of the Act or any Federal stations and regulations administered by registration modified by any Federal statutes and regulations administered by only in the Act of eggistration
You must comply Federal statises and regulations, but not limited to: regist You must comply with all the Act's requirements, then are and any medical device
and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device r seats of the Part 807), labeling (21 CFR Parts 801 mill oos); and good
and listing (21 CFR Part 807); labeling (21 CFR 803); and good
reporting (reporting of medical device and in B (reporting of medical device-related adverse events) (21 of 100 )) degreens
manufacturing practice requirements as set forth in the quality systems (QS) regulation ( CFR Part 820).
1
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you abon't office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 01160 of Dar reliestions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
S. H. Liu, Ph.D.
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name:
IND Drug Home Multi-Panel Test (2-5) - Cassette and Strip Formats IND Amphetamine Home Test - Cassette and Strip Formats IND Methamphetamine Home Test - Cassette and Strip Formats IND Cocaine Home Test - Cassette and Strip Formats IND Morphine Home Test - Cassette and Strip Formats IND Marijuana Home Test - Cassette and Strip Formats
Indications for Use:
The IND Drug Home Test is a rapid chromatographic immunoassay multi-panel or single drug test for the qualitative detection of one or more of the following drugs: Amphetamine, Methamphetamine, Cocaine, Marijuana, and Morphine in human urine. It is intended for overthe-counter use.
Drug Name (Code) Amphetamine (AMP) Methamphetamine (MET) Cocaine (COC) Marijuana (THC) Morphine (MOR)
Cut-off 1000 ng/mL 1000 ng/mL 300 ng/mL 50 ng/mL 300 ng/mL
The test is intended for over-the counter (OTC) use as the first step in a two step process to provide consumers with information concerning the presence of the above stated drugs or metabolites in a urine sample. The test provides only preliminary test results. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. GC/MS (Gas Chromatography / Mass Spectrometry) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Information regarding confirmatory testing, the second step in the process, is provided in the package labeling.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR -
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (01VD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121231