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Urine/CSF Albumin:

The Urine/CSF Albumin reagent is intended to be used for the quantitation of albumin concentration in human urine and cerebrospinal fluid (CSF) on the Beckman Coulter AU clinical chemistry systems as an aid in the diagnosis of kidney diseases. For in vitro diagnostic use only.

Urine/CSF Albumin Calibrator:

The Urine/CSF Albumin calibrator is intended to be used to calibrate the Urine/CSF Albumin reagent on the Beckman Coulter AU clinical chemistry systems. For in vitro diagnostic use only.

The Urine/CSF Albumin reagent kit is in a liquid, ready to use format. There are two kit concepts available. Each kit concept contains an R1 and an R2 reagent vial with different fill volumes. The Urine/CSF Albumin calibrator kit is in a liquid, ready to use format and contains 5 x 2 mL calibrator levels. It is packaged and sold separately to the reagent kit. Urine/CSF Albumin reagent is used to measure albumin concentration by a turbidimetric method. In the reaction, anti-human serum albumin antibodies combine with albumin from the sample to form immune complexes that scatter light in proportion to their size, shape and concentration. The absorbance of these aggregates is proportional to the albumin concentration in the sample. Change in absorbance is measured at 380nm with subtraction of a reference wavelength at 800nm. The Urine/CSF Albumin reagent and calibrator is designed for optimal performance on Beckman Coulter AU clinical chemistry analyzers.

This looks like a 510(k) premarket notification for a medical device: "Urine/CSF Albumin and Urine/CSF Albumin Calibrator." The document describes various analytical performance studies to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing a new clinical claim. Therefore, some of the requested information (like MRMC study effect size, number of experts for ground truth, adjudication method, and training set details) is not directly applicable to this type of submission.

However, I can extract and organize the available "acceptance criteria" (implicitly, the performance targets demonstrated) and "device performance" (the results of the studies).

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating equivalence through analytical performance, the "acceptance criteria" are implied by the precision, linearity, sensitivity, and interference limits typically expected for such devices, and demonstrated by the successful results presented. The "reported device performance" is the direct result from the validation studies.

• Low: 0.02 SD (0.9% CV)
• Mid: 0.02 SD (0.6% CV)
• High: 0.3 SD (1.4% CV)
  CSF:
• Low: 0.07 SD (1.0% CV)
• Mid: 0.4 SD (1.6% CV)
• High: 0.7 SD (1.9% CV) |
  | Precision (Within Laboratory/Total Imprecision) | Urine:
• Low: 0.07 SD (4.3% CV)
• Mid: 0.08 SD (2.5% CV)
• High: 0.4 SD (2.1% CV)
  CSF:
• Low: 0.11 SD (1.8% CV)
• Mid: 0.6 SD (2.4% CV)
• High: 0.9 SD (2.5% CV) |
  | Analytical Range (Linearity) | Urine: 0.7 - 45 mg/dL (acceptable linearity demonstrated)
  CSF: 1 - 45 mg/dL (acceptable linearity demonstrated) |
  | Reagent Shelf-Life Stability | 18 months at 2-8°C |
  | Calibrator Shelf-Life Stability | 18 months at 2-8°C |
  | Reagent On-Board Stability | 60 days |
  | Calibration Frequency | 60 days |
  | Calibrator Open Vial Stability | 30 days |
  | Sensitivity (LoB) | Urine: 0.00 mg/dL
  CSF: 0.00 mg/dL |
  | Sensitivity (LoD) | Urine: 0.07 mg/dL
  CSF: 0.13 mg/dL |
  | Sensitivity (LoQ) (≤ 0.7 mg/dL for urine, ≤ 1.0 mg/dL for CSF) | Urine: 0.70 mg/dL
  CSF: 0.70 mg/dL (met acceptance criteria) |
  | Interference (No Significant Interference: ≤ ± 10% or ± 0.2 mg/dL) | Urine:
• Calcium: NSI up to 78 mg/dL
• Creatinine: NSI up to 300 mg/dL
• Glucose: NSI up to 3000 mg/dL
• Urea: NSI up to 5000 mg/dL
• Ascorbic Acid: NSI up to 500 mg/dL
• Citrate: NSI up to 50 mg/dL
• Magnesium: NSI up to 400 mg/dL
• Oxalate: NSI up to 30 mg/dL
• Conjugated Bilirubin: NSI up to 40 mg/dL
• Hemoglobin: NSI up to 500 mg/dL
• Acetone: NSI up to 350 mg/dL
• Uric Acid: NSI up to 10 mg/dL
• Urobilinogen: NSI up to 2.25 mg/dL
• Acetaminophen: NSI up to 300 mg/dL
• Ibuprofen: NSI up to 400 mg/dL
• Metronidazole: NSI up to 600 mg/dL
• 5-aminosalicylic acid: NSI up to 150 mg/dL
  CSF:
• Hemoglobin: NSI up to 500 mg/dL
• Conjugated Bilirubin: NSI up to 40 mg/dL |
  | Prozone Tolerance | All samples from upper end of linear range up to claimed prozone tolerance generated a flagged result (indicating a result above the linear range), meaning no false low readings for high concentrations. Prozone high pool tested at ≥ 2000 mg/dL. |
  | Method Comparison (Urine) (vs. commercially available assay) | Slope = 1.09, Intercept = 0.03 mg/dL, r = 1.0; Sample range = 0.81 - 40.7 mg/dL (n=131) |
  | Method Comparison (CSF) (vs. commercially available assay) | Slope = 1.05, Intercept = -0.77 mg/dL, r = 0.99; Sample range = 1.72 - 41.2 mg/dL (n=131) |

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

• Precision (Repeatability and Total Imprecision): 3 sample levels (Low, Mid, High) for both Urine and CSF. Each level analyzed in duplicate, twice daily, over 20 working days (n=80 total measurements per level).
  • Data Provenance: Pooled human urine samples (spiked with purified human serum albumin) and pooled human CSF samples (diluted or spiked with purified human serum albumin). Origin country not specified but implied to be from samples handled in a clinical laboratory setting within the context of a US FDA submission. Prospective for the purpose of the study.
• Analytical Range (Linearity): 11 linearity concentration levels. Each dilution assayed in quadruplicate.
  • Data Provenance: Urine and CSF pools prepared by spiking with HSA or dilution. Origin country not specified. Prospective for the purpose of the study.
• Sensitivity (LoB, LoD, LoQ):
  • LoB/LoD: Replicate measurements on blank and low-level samples using three reagent lots. 60 blank replicates per reagent lot and 60 low-level sample replicates per reagent lot (total of 180 blanks and 180 low-level samples across 3 lots). Comprised of 4 blank samples and 4 low-level samples for urine and CSF, run 5-fold for 3 days. Four separate saline pools were used as blanks.
  • LoQ: Six pools (0.1, 0.2, 0.35, 0.5, 0.7, 1 mg/dL albumin in urine and CSF). Each pool measured in duplicate, twice daily, over 20 working days (n=80 total measurements per pool).
  • Data Provenance: Saline for blanks, quantified urine and CSF pools (diluted with saline) for low-level samples, and spiked urine and CSF pools for LoQ. Origin country not specified. Prospective for the purpose of the study.
• Interferences: Urine and CSF pools tested at two different albumin concentrations (1.5-3 mg/dL and 10-20 mg/dL for urine; 10-20 mg/dL and 25-35 mg/dL for CSF). Each interferent concentration tested in quadruplicate.
  • Data Provenance: Pooled human urine and CSF samples, spiked with purified human serum albumin and various interfering substances. Origin country not specified. Prospective for the purpose of the study.
• Prozone: Human urine and CSF spiked with human serum to create a prozone high pool (≥ 2000 mg/dL). Prozone panels run n=3.
  • Data Provenance: Human urine and CSF, spiked. Origin country not specified. Prospective for the purpose of the study.
• Method Comparison (Urine): n = 131 patient urine samples.
  • Data Provenance: Patient urine samples. Origin country not specified. Retrospective/prospective (typically, such studies use archived or freshly collected patient samples).
• Method Comparison (CSF): n = 131 patient CSF samples.
  • Data Provenance: Patient CSF samples. Origin country not specified. Retrospective/prospective (typically, such studies use archived or freshly collected patient samples).
• Reference Interval Validation (Urine): 20 urine samples.
  • Data Provenance: Urine samples. Origin country not specified. Prospective for the purpose of validation.

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

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement. The "ground truth" for the analytical performance studies is established by the known concentrations of calibrators, spiked samples, or comparison to a cleared reference method, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, "ground truth" is analytical, not based on expert review and adjudication.

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 an IVD device, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers." The device quantifies albumin concentration directly.

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

Yes, the device (Urine/CSF Albumin reagent and calibrator on Beckman Coulter AU clinical chemistry systems) is a standalone algorithm/instrument-based system that quantifies albumin concentration. Its performance is evaluated analytically, without a human-in-the-loop component for the direct measurement itself. Human oversight and interpretation of the numerical results are part of clinical practice, but the device's measurement function is autonomous.

7. The Type of Ground Truth Used

The "ground truth" or reference for the analytical performance studies relies on:

• Known concentrations: For precision, linearity, and sensitivity studies, this is achieved by using prepared pools with known added amounts of human serum albumin (HSA) or specific dilutions.
• Traceability to a Certified Reference Material: The Urine/CSF Albumin calibrator values are traceable to the International Federation of Clinical Chemistry Certified Reference Material ERM® - DA470k.
• Comparison to a legally marketed predicate device/method: For method comparison studies, the results are compared against another commercially available and presumably FDA-cleared assay for Urine Albumin and CSF Albumin.
• Literature-based reference intervals: Expected values/reference ranges are drawn from established medical literature.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense for diagnostic image interpretation or similar tasks. It's an immunoassay for quantitative analysis. The development process would involve internal R&D tests and optimization, but a defined training set for an AI model is not relevant here.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

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