(207 days)
MICROALBUSTIX Reagent Strips (OTC) are intended for home use by testing persons at risk for developing kidney damage
MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria), creatinine in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read visually by comparing the color of the reacted strip to the color chart on the bottle label. MICROALBUSTIX Reagent Strips (OTC) provide semiquantitative results and are intended for home use by persons at risk of developing kidney disease.
MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. MICROALBUSTIX Reagent Strips (OTC) are dipped into a urine specimen and "read" visually by comparing the color of the strip to a color chart on the label. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio can also be determined. Semi-quantitative results are available within one minute.
The provided text describes the MICROALBUSTIX™ Reagent Strips (OTC) and the study conducted to demonstrate their performance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table. However, the performance assessment concludes and effectively acts as the acceptance criteria that were met.
| Metric / Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Albumin Detection | Detects urinary albumin at 20 to 40 mg/L |
| Albumin-to-Creatinine Ratio | Detects albumin-to-creatinine ratio of 30 to 300 mg/g |
| User Performance | Lay users can obtain clinical test results that are substantially equivalent to current methods. |
| Comparison to Current Methods | Results comparable to results obtained by health care professionals. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "clinical and home use settings" and that "studies demonstrated that lay users can obtain clinical test results," implying a test set, but the number of participants or urine samples is not provided.
- Data Provenance: Not explicitly stated, though it's implied the studies were conducted in the US, as it's a US FDA submission. It refers to "clinical and home use settings," but doesn't specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not explicitly stated. The study compared results obtained by lay users to "currently used laboratory tests for microalbumin and creatinine in urine" and to "results obtained by health care professionals." This implies that the ground truth was established by laboratory methods and/or healthcare professionals, but the specific number or qualifications of these professionals beyond their general role are not provided.
4. Adjudication Method for the Test Set:
- Not explicitly stated. The document indicates a comparison between lay user results and "current methods" or "health care professionals," but doesn't describe any specific adjudication process (e.g., 2+1 review, etc.).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size:
- MRMC Study: The description implies a type of comparative effectiveness study in that lay users' performance was compared to "current methods" or "health care professionals." However, it is not formally described as a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" in the context of radiology or similar fields where that term is often used. It's more of a comparison of a new device's home-user performance against established laboratory/professional methods.
- Effect Size: Not quantified. The study concludes that lay users can obtain "substantially equivalent" and "comparable" results, but no specific effect size (e.g., in terms of sensitivity, specificity, accuracy improvement, or statistical significance of performance differences) is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes, in a way. The device itself is a "standalone" diagnostic device (reagent strip with visual read). The "human-in-the-loop" is the lay user who reads the strip. The study explicitly tests the performance of the device as read by lay users against established laboratory methods, which is the intended standalone performance from the user's perspective. It's not an "algorithm-only" study in the modern AI sense, but rather a study of the device's performance when used as intended without professional interpretation.
7. The Type of Ground Truth Used:
- Ground Truth: The ground truth was established using "currently used laboratory tests for microalbumin and creatinine in urine." This suggests a laboratory reference method or clinical gold standard as the ground truth.
8. The Sample Size for the Training Set:
- Not mentioned. The document describes performance assessment through clinical and home-use studies, but does not provide information about a separate training set. This is typical for traditional (non-AI/machine learning) diagnostic devices, which don't have a "training set" in the same way.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as a "training set" in the context of machine learning is not described for this device. The device's performance relies on the chemical reactions of the reagent strips.
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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.