(123 days)
CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is an O.T.C. home use test for nitrite and leukocytes (WBC's) in urine. It is intended to be used by lay persons to detect urinary tract infections.
CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is a plastic strip to which is affixed two reagent pads to test for nitrite and leukocytes (WBC's) in a urine specimen. The product is provided as a carton containing a bottle of five strips and a package insert.
The provided text describes the CHEK-STIX U.T.I. Test Strips, an over-the-counter (OTC) home use test for detecting urinary tract infections by testing for nitrite and leukocytes in urine.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Nitrite Test | Lay persons' results comparable to healthcare professionals' results | 97% agreement between lay persons and healthcare professionals |
| WBC Test | Lay persons' results comparable to healthcare professionals' results | 85% agreement between lay persons and healthcare professionals |
| Usability | Instructions are simple to understand for home users | "The instructions are simple to understand and afford the home user a way to detect urinary tract infections." |
Explanation of Implied Acceptance Criteria: The document directly states that the study was conducted "to demonstrate that lay persons can obtain results with CHEK-STIX U.T.I. comparable to results obtained by health care professionals." While no specific numerical threshold for "comparable" is given as an explicit acceptance criteria before the study, the reported agreement percentages (97% and 85%) are presented as evidence that this criterion was met.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions a "study was conducted in clinical settings," implying a prospective study involving human participants. However, the country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The "ground truth" in this context appears to be the results obtained by "health care professionals." The document does not specify the number of healthcare professionals involved or their specific qualifications (e.g., physician, nurse, medical technologist, years of experience).
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method. It simply refers to "agreement between the two groups" (lay persons and healthcare professionals), implying a direct comparison of results without a formal adjudication process for discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study, in the typical sense of evaluating human readers' improvement with AI vs. without AI assistance, was not conducted. This device is a biochemical test strip, not an AI-powered diagnostic system requiring human interpretation in conjunction with AI. The comparison is between lay users and healthcare professionals for interpreting the test strip's results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable in the traditional sense of an "algorithm only" performance for an AI device. The CHEK-STIX U.T.I. Test Strips are a standalone device that provides a visual result. The "performance" being evaluated is the ability of human users (lay persons) to correctly interpret the results compared to human experts (healthcare professionals). The device itself is not an algorithm for which standalone performance (without human interpretation) would be relevant in this context.
7. The Type of Ground Truth Used:
The ground truth used was expert assessment/interpretation. Specifically, it was the results obtained by "health care professionals" using the same type of test pads.
8. The Sample Size for the Training Set:
This information is not provided. The document does not describe a separate training set. The study detailed appears to be a single evaluation, not a training/testing paradigm as would be seen for machine learning models.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the process of establishing its ground truth is not described.
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JU - 5 1996 510(k) SAFETY AND EFFECTIVENESS SUMMARY June 19, 1996 Prepared: Bayer Corporation, Business Group Diagnostics Submitter: 1884 Miles Avenue, P. O. Box 70 Address: Elkhart, IN 46515 (219) 262-6929 Rosanne M. Savol, R.A.C. Contact: Manager, Regulatory Affairs Trade/Proprietary Name: CHEK-STIX U.T.I. Test Strips for Device: the Detection of Urinary Tract Infection Test for nitrite in urine Common/Usual Name: Test for leukocytes (WBC's) in urine Document Control Number: K960888 Classification Division of Clinical Laboratory Devices Information: Panel - Clinical Chemistry and Toxicology Classification Codes -- CH(75) JMT [Diazo (Colorimetric), Nitrite (Urinary, Non-Quant.)] CH(75) LJX (Urine Leukocyte Test) Predicate Device: MULTISTIX® 2 Reagent Strips for Urinalysis Manufactured by Bayer Corporation CHEK-STIX U.T.I. Test Strips for the Detection of Device Description: Urinary Tract Infection is a plastic strip to which is affixed two reagent pads to test for nitrite and leukocytes (WBC's) in a urine specimen. The product is provided as a carton containing a bottle of five strips and a package insert. CHEK-STIX U.T.I. Test Strips for the Detection of Intended Use: Urinary Tract Infection is an O.T.C. home use test for nitrite and leukocytes (WBC's) in urine. It is intended to be used by lay persons to detect urinary tract infections.
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Technological Characteristics:
CHEK-STIX U.T.I. Test Strips are dry reagent strips which, when in contact with a urine specimen, reacts with nitrite and leukocyte esterase in the specimen to give a pink and a purple color. The color of the strip is compared to a color chart on the bottle label to obtain the result. CHEK-STIX U.T.I. has the same test pads as are on strips used by doctors and clinical labs.
Assessment of Performance:
A study was conducted in clinical settings to demonstrate that lay persons can obtain results with CHEK-STIX U.T.I. comparable to results obtained by health care professionals.
Agreement between the two groups was 97% for the nitrite test and 85% for the WBC test.
Conclusion:
The results of the patient-use evaluation demonstrate that lay persons can use CHEK-STIX U.T.I. Test Strips and obtain results that are in agreement with results obtained by health care professionals. The instructions are simple to understand and afford the home user a way to detect urinary tract infections.
§ 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.