(551 days)
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No
The summary describes a simple chemical test strip for detecting nitrite and leukocytes in urine, with no mention of AI, ML, image processing, or complex data analysis.
No
This device is a diagnostic tool used to screen for UTIs, not to treat them.
Yes
The device is described as an "aid in the screening of urinary tract infection," which indicates its use in identifying or detecting a medical condition, thus classifying it as a diagnostic device.
No
The device is a physical test strip used to detect substances in urine, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of nitrite and leukocytes in urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Purpose: The purpose is to aid in the "screening of urinary tract infection." This is a diagnostic purpose, helping to identify a potential medical condition.
- Sample Type: The device tests "urine," which is a biological sample.
- Testing Method: The description mentions "dipping the test strip into it," indicating a test performed on the sample.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IND Urinary Tract Infection (UTI) Test Strips are intended for qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infection in persons with signs and symptoms of urinary tract infection. Testing of urine is performed by urinating into a sample cup and briefly dipping the test strip into it. This test is intended for over-the-counter home use only.
Product codes
NGJ, LJX
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
over-the-counter home use
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
IND Diagnostics, Inc c/o Kai Lou 1629 Fosters Way Delta, B.C. Canada V3M 6S7
APR 1 7 2012
Re: K103037
Trade Name: IND Urinary Tract Infection (UTI) Test Strips Regulation Number: 21 CFR §862.1510 Regulation Name: Nitrite (nonquantitative) test system Regulatory Class: Class I, meets limitations to exemption 21 CFR 862.9 (c)(9) Product Codes: NGJ, LJX Dated: April 9, 2012 Received: April 11, 2012
Dear Kai Lou:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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) 796-5760. For questions 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 vours,
Courtney 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
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Indications for Use
510(k) Number (if known):
Device Name:
IND Urinary Tract Infection (UTI) Test Strips
Indications For Use:
The IND Urinary Tract Infection (UTI) Test Strips are intended for qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infection in persons with signs and symptoms of urinary tract infection. Testing of urine is performed by urinating into a sample cup and briefly dipping the test strip into it. This test is intended for over-the-counter home use only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (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 (OIVD)
· Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103037