(432 days)
URITEST 10 Urinalysis Reagent Strips provide qualitative and sem-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.
ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of use in screening at-risk patients to assist diagnosis in the following areas:
Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration
Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative for pH, specific gravity, ketones. blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Bayer® Family of Clinitek Urine Analyzers. The results are available within 120 seconds. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.
The provided text describes the URITEST 10 Urinalysis Reagent Strips but lacks specific details regarding acceptance criteria and the comprehensive study methodologies typically found in a full submission. However, based on the available information, I can construct a response.
Acceptance Criteria and Device Performance Study
The document states that the performance of URITEST 10 Urinalysis Reagent Strips was compared to the legally marketed predicate device, Bayer MULTISTIX 10 SG Reagent Strips. The overarching acceptance criterion appears to be "performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips."
Since specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not provided, I will infer that the reported performance implies a demonstration of equivalence or non-inferiority to the predicate device in terms of qualitative and semi-quantitative results for all ten analytes.
1. Table of Acceptance Criteria and Reported Device Performance
| Analyte | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| pH | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | "URITEST 10 Urinalysis Reagent Strips provide 10 reagent tests of urinalysis that are similar in composition and performance to reagent tests currently provided by devices on the U.S. market." "ARJ Medical studies showed that URITEST 10 Urinalysis Reagent Strips provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC, hospital, and clinical settings." |
| Specific Gravity | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Ketones | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Blood | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Protein | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Nitrite | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Leukocytes | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Glucose | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Bilirubin | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
| Urobilinogen | Comparable results to Bayer MULTISTIX 10 SG Reagent Strips | (Same as above) |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the test set used in the clinical performance study. It only mentions "a clinical laboratory setting" for the study.
- Data Provenance: The data provenance is not explicitly stated in terms of country of origin. The study was conducted in a "clinical laboratory setting" and involved professional users in "centralized and point-of-care (POC) hospital clinical and doctor's office setting." It's reasonable to infer these settings are within the United States, given the FDA 510(k) submission. The study was prospective in nature as it involved collecting and testing urine samples using the URITEST 10 strips and comparing them to results from the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not state the number of experts or their specific qualifications for establishing ground truth for the test set. Instead, the "ground truth" for comparison was established by the results obtained from the Bayer MULTISTIX 10 SG reagent strips, which served as the reference standard in this equivalence study. The tests were read both visually and instrumentally by "professional users" (medical technologists).
4. Adjudication Method for the Test Set
- The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was derived from the predicate device's results, with the URITEST 10 results being compared to them.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not conducted. This device is a traditional urinalysis reagent strip, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation in that context. The study did involve both visual and instrumental readings by professional users, but this is a standard practice for this type of device, not an AI assistance evaluation.
6. Standalone Performance Study (Algorithm Only)
- The concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable here. The device is a physical reagent strip that requires either visual interpretation by a human or instrumental reading (on Bayer Clinitek Urine Analyzers). It is not an algorithm that operates independently.
7. Type of Ground Truth Used
- The type of ground truth used was comparative performance against a legally marketed predicate device (Bayer MULTISTIX 10 SG Reagent Strips). This is a common approach for 510(k) submissions demonstrating substantial equivalence. The predicate device's results, obtained through standard laboratory methods and visual/instrumental readings by professionals, served as the reference.
8. Sample Size for the Training Set
- The document does not mention a "training set" in the context of device development. This terminology is typically associated with machine learning or AI algorithms, which are not described as part of this device's development or operation. The URITEST 10 is a chemical reagent-based test strip.
9. How Ground Truth for the Training Set Was Established
- As there is no mention of a "training set" for an algorithm, the question of how its ground truth was established is not applicable to this 510(k) summary.
§ 862.1785 Urinary urobilinogen (nonquantitative) test system.
(a)
Identification. A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.(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.