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Good Biotech Corp. (GBC) Microalbumin TIA system is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). Measurement of albumin aids in the diagnosis of kidney disease.

GBC mAlb Calibrator Set 200 is intended to be used with GBC Microalbumin TIA for the quantitative determination of microalbumin in urine samples.

GBC Microalbumin Controls are intended to be used as the assayed quality control material for the urinary albumin analysis.

For In Vitro Diagnostic Use.

Good Biotech Corp. Microalbumin TIA is a ready to use reagent for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). When microalbumin of the urine sample encounters with duck anti-albumin antibody, the agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 340 nm is proportional to the albumin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual microalbumin concentration of the urine sample is determined by interpolation of the calibration curve obtained by standard samples with known albumin concentrations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microalbumin TIA device:

Acceptance Criteria and Device Performance Study

The provided document describes a 510(k) submission for the Good Biotech Corp. Microalbumin TIA system, which includes the TIA reagent, mAlb Calibrator Set 200, and mAlb Control-L, Control-H. The study presented is a comparative performance study to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are inferred from the comparison to predicate devices, focusing on correlation coefficients. The document does not explicitly state pre-defined numerical thresholds as "acceptance criteria" but rather presents the results of the comparison and concludes equivalence.

Note: The document states "high correlation coefficients" as the basis for substantial equivalence, implying that correlation values close to 1.0 (e.g., above 0.95 or 0.98) would be considered acceptable. The reported values of 0.997 and 0.998 clearly meet this implied criterion. Slopes close to 1.0 and intercepts close to 0 would also indicate good agreement, which are reasonably met here for the purpose of demonstrating equivalence in a 510(k) submission in vitro diagnostic.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: 50 urine samples.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given that it's a comparative performance study for a diagnostic device, the samples would typically be collected prospectively or from a well-characterized biobank for analytical validation. The company is based in Taiwan, so the samples were likely collected there, but this is not confirmed.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The study is a comparative analytical performance study against existing, legally marketed diagnostic devices (Randox Microalbumin Test kit and Wako Micro-Albumin B). The "ground truth" for each sample is the measurement obtained from these predicate devices. There is no mention of expert consensus or interpretation being used to establish a "ground truth" independent of the and predicate device measurements.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study compares the quantitative results of the GBC Microalbumin TIA system directly against the results from the predicate devices. There is no need for human adjudication of results in this type of analytical validation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for AI-driven image analysis or diagnostic support systems where human readers interpret medical images or data. The GBC Microalbumin TIA system is an in vitro diagnostic (IVD) Turbidimetric Immunoassay (TIA) that provides a quantitative measurement, not an AI system assisting human readers.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the described study essentially represents the "standalone" performance of the GBC Microalbumin TIA system. As an IVD, the device itself performs the measurement (generating a quantitative result) without human input in the interpretation loop, other than standard laboratory practices for sample handling and running the assay. The performance demonstrated (correlation with predicate devices) is of the device on its own.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this analytical validation is established by the measurements obtained from the predicate devices (Randox Microalbumin Test kit and Wako Micro-Albumin B). This is a common approach for demonstrating substantial equivalence for in vitro diagnostics where a new device's analytical performance is compared against established, legally marketed methods.

8. Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided in the document. For an IVD like this, there isn't typically a "training set" in the machine learning sense. However, the manufacturer would have performed internal R&D and optimization studies (which might involve various sample sets) to develop and refine the reagent and assay method before the pivotal validation study. The 50 urine samples refer to the validation or test set used for the 510(k) submission.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there's no explicitly defined "training set" with ground truth in the context of this analytical performance study. The development process would have involved establishing the accuracy and precision of the assay, likely using internal reference materials, calibrated standards, and known-concentration samples, but these are part of R&D and not typically detailed as a "training set" in a 510(k) summary for an IVD.

Ask a specific question about this device

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table and the study description as requested. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not typically include the detailed performance study results, sample sizes, ground truth establishment methods, or expert qualifications that would be present in a submission for acceptance criteria.

The information I can extract is limited to:

• Device Name: Microalbumin
• Intended Use: Quantitative determination of low-level albumin in human urine, for in vitro diagnostic use in a diagnostic laboratory setting by qualified laboratory technologists. It is indicated as a useful indicator of early glomerular disease and to predict the development of diabetic nephropathy and its mortality risk.
• Regulatory Class: Class II
• Product Code: DDZ; JIT

To fulfill your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) or the full 510(k) submission, which often includes details of the performance studies.

Ask a specific question about this device

Ask a specific question about this device