(45 days)
The DCA 2000+ Microalbumin/Creatinine Assay is a professional use device for the measurement of microalbumin, creatinine and albumin/creatinine ratio in urine. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.
The DCA 2000+ Microalbumin/Creatinine Assay is a convenient, quantitative method for measuring low concentrations of albumin (microalbumin), creatinine and albumin/creatinine ratio in urine. The DCA 2000+ Microalbumin/Creatinine Assay is designed to be used with the DCA 2000+ Analyzer and the DCA 2000+ Microalbumin/Creatinine Control Kit. It is selfcontained reagent/instrument system that is suitable for use in decentralized, or point-of-care laboratories such as physician office laboratories, clinics and hospitals.
The provided text describes a medical device, the DCA 2000+ Microalbumin/Creatinine Assay, and presents a summary of its performance assessment. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study information.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "The studies demonstrated that typical users in decentralized, point-of-care laboratories can obtain clinical test results that are substantially equivalent to current methods." However, it does not explicitly state specific numerical acceptance criteria (e.g., target accuracy, precision, sensitivity, specificity, or correlation coefficients).
Therefore, a table cannot be fully constructed with quantitative acceptance criteria from the provided text.
| Performance Metric | Acceptance Criteria (Not explicitly stated) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantial equivalence to current methods | Clinical test results substantially equivalent to current methods |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The studies were conducted in "clinical settings by typical users of the system." It implies real-world settings but does not specify country of origin 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 specified in the provided text. The "ground truth" was established by "currently used tests for microalbumin and creatinine," which are predicate devices. The expertise related to these predicate methods is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified in the provided text.
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
- MRMC Study: This device is for in-vitro diagnostic testing (analyzing urine samples), not for image interpretation by human radiologists. Therefore, an MRMC study in the context of human readers interpreting images is not applicable to this device.
- Effect size of human reader improvement with AI: Not applicable for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The DCA 2000+ system is described as a "self-contained reagent/instrument system" that "automatically performs all the measurements and calculations." This indicates that the device operates in a standalone manner once the sample is loaded, providing results without continuous human interpretation of the assay's output during the measurement process. The comparison was against "current methods," implying a standalone comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth was established by "currently used tests for microalbumin and creatinine," which are listed predicate devices (e.g., Incstar® Antibody Reagent Set, Diagnostic Products Corporation Double Antibody Albumin RIA, automated Jaffe methods). This implies a comparison to established, validated laboratory methods rather than pathology, expert consensus on images, or outcomes data.
8. The sample size for the training set
The document describes performance assessment but does not mention a "training set" as is common in AI/machine learning contexts. This is a traditional IVD device, not an AI-driven one.
9. How the ground truth for the training set was established
Not applicable, as a training set in the AI sense is not mentioned.
§ 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.