Search Results

For IN VITRO diagnostic use.

There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but elevated urinary albumin levels, or microalbuminuria, refers to a level of the human protein albumin in urine above about 18 mg/L. Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifies samples as positive based on their being above or below a level of 18 mg/L.

Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8); hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).

Not Found

The provided document is a 510(k) clearance letter from the FDA for the ImmunoDip™ Urinary Albumin Test. It indicates that the device is substantially equivalent to a legally marketed predicate device.

However, the document DOES NOT contain information regarding:

• Specific acceptance criteria values or a table of reported device performance values. The document only states the device "classifies samples as positive based on their being above or below a level of 18 mg/L."
• A detailed description of any study proving the device meets acceptance criteria. It refers to "Scientific studies indicate that proper control of blood glucose...help slow or prevent kidney damage," but this is background information, not a study of the ImmunoDip device itself. Similarly, "One study found 45% of the insulin-dependent diabetics develop serious kidney disease" is general epidemiological data.
• Sample sizes for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

Based on the available information from the document, here's what can be extracted, along with the acknowledgement of missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Not specified in the provided text.

4. Adjudication Method for the Test Set:

• Not specified in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, the document does not mention an MRMC study or comparative effectiveness with human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The device is described as an "ImmunoDip™ Urinary Albumin Test," implying a rapid diagnostic test kit rather than a software algorithm. Therefore, "standalone algorithm performance" as typically understood for AI/software devices is not applicable or discussed.

7. The Type of Ground Truth Used:

• Not specified in the provided text. The device is intended to classify samples based on an 18 mg/L threshold, implying a quantitative measurement of urinary albumin would be the "ground truth" against which the test's classification is compared, but this is not explicitly stated as the methodology for evaluation.

8. The Sample Size for the Training Set:

• Not specified in the provided text.

9. How the Ground Truth for the Training Set was Established:

• Not specified in the provided text.

Summary of what is present:

• Device Name: ImmunoDip™ Urinary Albumin Test
• Indications for Use: For IN VITRO diagnostic use. To determine albumin in urine at low levels (microalbuminuria), classifying samples as positive if above 18 mg/L. Helpful for early detection and treatment of patients at risk for renal disease (e.g., Type 1 and Type 2 diabetes, hypertension, renal disease in pregnancy).
• Regulatory Clearance: 510(k) clearance (K022538) from FDA, determined substantially equivalent to a predicate device. Regulatory Class I, Product Code JIR.

Limitations:

The provided document is limited to the FDA's 510(k) clearance letter and an "Indications for Use" statement. It does not contain the detailed study protocols, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a scientific publication. For that information, one would need to refer to the full 510(k) submission K022538, which is often available through the FDA's public database.

Ask a specific question about this device