(551 days)
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.
Not Found
Here's an analysis of the provided FDA 510(k) summary, specifically looking for acceptance criteria and study details.
Crucial Note: The provided document is an FDA 510(k) clearance letter and an "Indications for Use" statement. It does not contain the detailed study report, acceptance criteria, or performance data itself. FDA clearance letters only state that the device has been found substantially equivalent to a predicate device. To get the information you're asking for, one would typically need access to the full 510(k) submission, which is not usually publicly available in this level of detail.
Therefore, many of your questions cannot be answered from the provided text. I will indicate where the information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not provided in the clearance letter) | (Not provided in the clearance letter; the letter only indicates clearance, not specific performance metrics.) |
Explanation: The FDA clearance letter for K103037 for the "IND Urinary Tract Infection (UTI) Test Strips" does not detail the specific acceptance criteria or the reported device performance metrics (e.g., sensitivity, specificity) from the studies conducted. This information would typically be found in the full 510(k) submission's performance section.
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not provided.
- Data Provenance (country of origin, retrospective/prospective): Not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of experts: Not provided.
- Qualifications of experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication method: Not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: Unlikely, as this is a diagnostic test strip for over-the-counter home use, not an imaging device typically involving multiple human readers interpreting complex images. The device is intended for direct user interpretation. Therefore, a traditional MRMC study as commonly understood for AI in medical imaging would not be applicable or expected.
- Effect size of improvement with AI vs. without AI: Not applicable, as this is a standalone test strip, not an AI-assisted interpretation system for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. As a chemical test strip, its performance is inherently "standalone" in that it provides a direct result (color change) based on chemical reactions, without an algorithmic interpretation layer in the same way an AI software would operate. The user directly observes the result. The studies would have evaluated the accuracy of these chemical reactions against a reference method.
7. The Type of Ground Truth Used
- Type of Ground Truth: While not explicitly stated in this document, for a UTI test strip detecting nitrite and leukocytes, the ground truth would almost certainly be established through laboratory-based microbiological urine culture (for confirming actual UTI presence and specific pathogens) and potentially microscopic analysis of urine sediment (for leukocyte presence).
8. The Sample Size for the Training Set
- Sample size for training set: Not provided. For a non-AI diagnostic strip, "training set" isn't a conventional term in the same way as for machine learning. Instead, product development and optimization might involve iterative testing, but this wouldn't typically be called a "training set" in the context of FDA submissions for such devices.
9. How the Ground Truth for the Training Set was Established
- Ground truth for training set: Not provided. As noted above, the concept of a "training set" with established ground truth is less directly applicable for this type of chemical diagnostic strip. Optimization and development would rely on comparison to established laboratory methods.
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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
§ 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.