(94 days)
The Microalbumin assay is used for the quantitation of low levels of albumin in human urine. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques, the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
Microalbumin is an in vitro diagnostic assay for the quantitative determination of low levels of albumin in human urine. Antibodies to albumin combine with albumin in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 340 and 700 nm, is directly proportional to the concentration of microalbumin in the sample.
Here's a breakdown of the acceptance criteria and study information for the µAlb device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation | The correlation coefficient = 0.9985 with the predicate device (K-ASSAY® Microalbumin on Hitachi® 717 Analyzer). |
| Slope | The slope = 1.032 with the predicate device. |
| Y-intercept | The Y-intercept = -0.132 mg/dL with the predicate device. |
| Precision | - Within-run, between-run, and between-day studies performed. |
- Total %CV for Level 1/Panel 201: 6.4%
- Total %CV for Level 2/Panel 202: 3.8% |
| Assay Range | 0.441 to 30.86 mg/dL |
| Limit of Quantitation (Sensitivity) | 0.441 mg/dL |
Study Information
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The text mentions "comparative performance studies were conducted" and "precision studies were conducted using two levels of control material." It does not provide the specific number of human urine samples used for the method comparison or the number of replicates/samples for the precision studies.
- Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
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)
- Not applicable as this is an in vitro diagnostic (IVD) assay for quantitative determination of albumin, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this type of device is typically established by comparative analysis with a legally marketed predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used when multiple human readers interpret results for establishing ground truth in subjective assessments. This device involves quantitative measurements.
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
- Not applicable. This is not an AI-assisted device or an imaging device, thus an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The study described is a standalone performance assessment of the µAlb assay. It is an in vitro diagnostic device, and its performance is evaluated directly through chemical analysis and comparison to a predicate device, not in conjunction with human interpretation of its results on a case-by-case basis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" (or reference standard) for the comparative performance study was the K-ASSAY® Microalbumin on the Hitachi® 717 Analyzer. The study demonstrated substantial equivalence by comparing the µAlb assay's results against this predicate device, which itself is an established method for microalbumin quantitation.
8. The sample size for the training set
- Not applicable. This document describes the validation of a new in vitro diagnostic assay (based on immunoassay principles), not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 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.