(162 days)
URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening in the following areas:
- Kidney function
- Urinary tract infections
- Carbohydrate metabolism (e.g. diabetes mellitus)
- 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.
URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semiquantitative tests for ascorbic acid, pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin and urobilinogen in urine. URISTIK H Series Reagent Strips For Urinalysis 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 Dirui H-50, H-100, or H-500 Urine Analyzer. The results are available within one minute. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.
The provided text describes the regulatory filing for the URISTIK H Series Reagent Strips but lacks specific quantitative acceptance criteria or detailed study results with exact performance metrics. However, it does provide a summary of the studies conducted and the conclusions reached regarding performance.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) are not explicitly stated in the provided document. Similarly, detailed quantitative performance data (like exact percentages of agreement or accuracy values) are not reported.
The document broadly states:
- "The studies demonstrated that professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings can obtain valid urinalysis test results."
- "Dirui studies showed that the URISTIK H Series Reagent Strips For Urinalysis provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC settings."
Therefore, a table with specific acceptance criteria and reported performance cannot be fully constructed from the given text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "clinical laboratory settings."
- Data Provenance: The studies were conducted in "clinical laboratory settings by professional users." The product's manufacturer is Changchun Dirui Industrial Co., Ltd. (China), but the specific locations (e.g., countries) where these clinical studies were performed are not detailed. It is not explicitly stated whether the data was retrospective or prospective, but clinical laboratory studies often imply prospective collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications: "Professional users" performed the tests and comparisons. Implicitly, these would be laboratory professionals or clinicians, but specific qualifications (e.g., "clinical pathologist with 5 years of experience") are not provided.
4. Adjudication Method for the Test Set
- The document states that "The results were compared to results obtained from Bayer MULTISTIX 10 SG Reagent Strips and from laboratory test methods." This implies a comparison against established methods. However, the specific adjudication method (e.g., whether multiple experts reviewed discrepant results, or if there was a predefined algorithm for determining a 'true' result) is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- It is not explicitly stated that an MRMC comparative effectiveness study was done regarding human readers improving with or without AI assistance. The device is a reagent strip for urinalysis, which is typically read visually or by a dedicated analyzer; it's not an AI-assisted diagnostic imaging device for human interpretation. The study focused on the performance of the strips when read visually by professional users versus instrumentally, and in comparison to predicate devices and laboratory methods.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, performance was assessed both visually (implying human-in-the-loop) and "instrumentally using Dirui H Series Urine Analyzers." The instrumental reading can be considered a form of standalone performance for the combined strip-analyzer system, independent of visual human interpretation. However, the exact performance metrics for the instrumental reading versus visual reading are not provided.
7. Type of Ground Truth Used
- The ground truth was established by "laboratory test methods." These "laboratory test methods" are implied to be established, more definitive reference methods for the urinalysis parameters being assessed (e.g., chemical assays for glucose, microscopic examination for blood cells).
8. Sample Size for the Training Set
- The document does not mention a training set or its sample size. This is typical for reagent strip validation, which often focuses on clinical performance rather than machine-learning model training.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned, the method for establishing its ground truth is also not described.
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.