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The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

The Creatinine LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. To calibrate the test kit, a calibrator is used that has values determined by a similar method.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Creatinine LiquiColor® device:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than setting new, explicit acceptance criteria for novel performance claims. However, the performance data presented implicitly sets the "acceptance criteria" by showing performance comparable to the predicate device and within generally accepted analytical limits for clinical assays.

Here's a table summarizing the reported performance, with the understanding that these values, by virtue of leading to substantial equivalence, implicitly served as the 'acceptance criteria' for this submission.

| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-|
| Method Comparison (Correlation with Predicate) | Serum: Correlation coefficient (r) ≥ ~0.99 (based on observed 0.9991) Regression slope (y) ≈ 1.0 (based on observed 1.4815x - 0.5831, acknowledging a notable slope difference, but still showing strong correlation). | Serum: r = 0.9991, regression equation: y = 1.4815x - 0.5831 |
| | Urine: Correlation coefficient (r) ≥ ~0.98 (based on observed 0.9854) Regression slope (y) ≈ 1.0 (based on observed 1.0545x + 0.3607, showing good agreement). | Urine: r = 0.9854, regression equation: y = 1.0545x + 0.3607 |
| Precision (Intra-assay CV%) | Low CV% (e.g., < 2%) across different concentrations. | Intra-Assay: 0.610 mg/dL: CV% = 1.14%; 1.107 mg/dL: CV% = 0.84%; 5.733 mg/dL: CV% = 0.41% |
| Precision (Inter-assay CV%) | Low CV% (e.g., < 2%) across different concentrations. | Inter-Assay: 0.629 mg/dL: CV% = 1.98%; 1.134 mg/dL: CV% = 0.98%; 5.814 mg/dL: CV% = 0.38% |
| Sensitivity | Low detection limit, clinically relevant (e.g., < 0.1 mg/dL for creatinine). | 0.04 mg/dL (based on instrument resolution A = 0.001) |
| Linearity | Wide linear range, covering clinically relevant creatinine concentrations (e.g., up to 200 mg/dL for severe renal impairment). | Linear to 200 mg/dL |

Note on "Acceptance Criteria": As this is a 510(k) summary, formal, explicit "acceptance criteria" (e.g., "The device must achieve an R-squared of X or greater compared to the predicate") are not typically stated in the summary itself. The demonstration of "Substantial Equivalence" inherently means that the device's performance, as measured by these studies, met the FDA's unwritten (or, in some cases, guidance-specified) expectations for equivalence to the predicate. The reported values are the results that led to this determination.

Study Details

The provided text describes analytical studies to demonstrate "substantial equivalence" of the Creatinine LiquiColor® test to a predicate device (Roche Diagnostics Creatinine reagent, 510(k) K941837).

1. Sample Sizes Used for the Test Set and Data Provenance:

   • Serum: n = 30 specimens
   • Urine: n = 37 specimens
   • Data Provenance: Not explicitly stated (e.g., country of origin, demographics of sample donors). It is, however, implied to be a prospective collection of patient samples for comparison testing, as common in method comparison studies. It is not specified if these were "retrospective" (archived samples) or "prospective" (newly collected for the study).

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

   • Not applicable. This device is a quantitative clinical chemistry assay. The "ground truth" for the test set is established by the predicate device's measurement (Roche Diagnostics Creatinine reagent), not by expert opinion. The study aims to show correlation between the new device's measurements and the predicate's measurements. There is no mention of experts establishing a "ground truth" in terms of diagnosis or interpretation.

3. Adjudication Method:

   • Not applicable. As described above, the study compares quantitative measurements from two different analytical methods. There is no diagnostic endpoint requiring adjudication by experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases. This device is a quantitative in vitro diagnostic assay.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the performance data presented (Correlation, Precision, Sensitivity, Linearity) represents the standalone performance of the Creatinine LiquiColor® enzymatic assay. There is no human interpretation component in the measurement or result generation for this type of IVD, so the "algorithm only" performance is the only performance. The device provides a quantitative creatinine value without human interpretation required for the numerical result itself.

6. Type of Ground Truth Used:

   • Predicate Device Measurements: The "ground truth" in this context is the quantitative creatinine concentration determined by the predicate device (Roche Diagnostics Creatinine reagent). The study aims to demonstrate that the new device's results are in agreement with these "ground truth" values established by the already-approved predicate method.

7. Sample Size for the Training Set:

   • Not applicable. This device is an enzymatic chemical assay, not a machine learning or AI algorithm in the contemporary sense that would require a "training set." The methodology is based on established biochemical reactions rather than learned patterns from data.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" for this type of device. The assay's mechanism is defined by the chemical reactions rather than statistical learning from data.

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