(261 days)
Urine strips are for "in vitro" diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations.
Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine.
Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The test is to be read visually.
Wiener lab. Urine Strip are plastic strips to which glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leucocytes and ascorbic acid reagents pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The instructions for use must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.
The provided text is a 510(k) Summary for the "Wiener lab. Urine Strip" device. It outlines the device's intended use and claims substantial equivalence to the predicate device, Bayer Multistix® 10SG. However, it does not contain a study that explicitly details acceptance criteria and proves the device meets those criteria with specific performance metrics such as sensitivity, specificity, or accuracy.
The document focuses on:
- Device Description: What the device is and how it works.
- Intended Use: The diagnostic purposes of the device.
- Equivalencies and Differences to Predicate Device: A comparison of methodologies and sensitivities for each parameter with the predicate device.
Therefore, many of the requested details cannot be extracted from this specific document.
Here's the information that can be extracted or inferred from the provided text, along with what is missing:
1. A table of acceptance criteria and the reported device performance
The document lists "Sensitivity" for several parameters, comparing the Wiener lab. Urine Strip to the predicate device. While this indicates detection limits, it doesn't explicitly state "acceptance criteria" against which these sensitivities are being measured, nor does it present full performance metrics (like accuracy, specificity, etc.) typically found in a clinical study report.
| Parameter | Wiener lab. Urine Strip Sensitivity | Predicate Device (Bayer Multistix® 10SG) Sensitivity (for comparison) | Acceptance Criteria (Not Explicitly Stated as AC) |
|---|---|---|---|
| Proteins | 0.15-0.3 g/l (15-30 mg/dl) | (Not explicitly listed for predicate in this section) | Not explicitly stated |
| Blood | 150-620 µg/l (0.015-0.062 mg/dl) | (Not explicitly listed for predicate in this section) | Not explicitly stated |
| Nitrite | 0.05-0.15 mg/dl | 0.06-0.1 mg/dl | Not explicitly stated |
| Glucose | 100 mg/dl | 75-125 mg/dl | Not explicitly stated |
| Ketones | 5 mg/dl (acetoacetate) | 5-10 mg/dl (acetoacetic acid) | Not explicitly stated |
| Bilirubin | 0.5 mg/dl | 0.4-0.8 mg/dl | Not explicitly stated |
Missing:
- Explicitly defined acceptance criteria values for each performance metric. The document mentions "substantial equivalency" but does not define quantitative thresholds for this equivalency in terms of performance.
- Full device performance report (e.g., accuracy, sensitivity, specificity, PPV, NPV) against a defined ground truth for various concentrations for all analytes. The provided sensitivities are detection limits, not comprehensive performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing: This information is not provided in the 510(k) summary. The document does not describe a specific clinical study with a test set. It primarily compares the methodologies and stated sensitivities/detection limits to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing: This information is not provided. There is no mention of an expert panel or ground truth establishment process for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing: Not applicable, as no external test set or adjudication process is described in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing: Not applicable. The device is a chemical reagent strip read visually against color blocks, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Missing: Not applicable. The device is a chemical reagent strip, not an algorithm. Its performance is inherent in its chemical reactions and visual color change. The instructions state "Results are obtained by direct comparison of the test strip with the chemical-reaction and optical features of the reagent strip itself and comparison with color blocks. It is not an algorithm-only device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing: The document does not describe a specific "ground truth" reference method for a clinical study. The comparison is based on the stated methodologies and sensitivities of the new device and the predicate device, implying that the performance claims are based on internal validation using established analytical methods rather than a head-to-head clinical trial with patient outcomes.
8. The sample size for the training set
Missing: The document does not describe a "training set" as this is not an algorithm-based device that undergoes machine learning training.
9. How the ground truth for the training set was established
Missing: Not applicable, as this is not an algorithm-based device.
§ 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.