(113 days)
Yumizen C1200 ALP reagent is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitropherylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Yumizen C1200 Albumin reagent is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
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The provided text describes analytical performance characteristics and comparison studies for two in vitro diagnostic reagents, Yumizen C1200 ALP and Yumizen C1200 Albumin, intended for use on the Yumizen C1200 clinical chemistry analyzer. The document is a 510(k) summary, demonstrating substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the studies performed, structured according to your request:
Acceptance Criteria and Reported Device Performance
For both assays, the acceptance criteria are implicitly defined by the successful demonstration of performance characteristics within established guidelines (CLSI) and comparison to their respective predicate devices. The "Results are within predefined acceptance criteria" statements affirm that the tested parameters met the company's internal benchmarks, which are aligned with industry standards for analytical performance.
Here's a table summarizing the reported device performance for key analytical characteristics:
| Acceptance Criteria Category | Yumizen C1200 ALP Reported Performance | Yumizen C1200 Albumin Reported Performance |
|---|---|---|
| Measuring Range | LoD = 1.40 U/L, LoQ = 5.85 U/L, Linearity 0-1620 U/L. Measuring Range: 6 to 1200 U/L (up to 4800 U/L with post-dilution) | LoD = 0.57 g/L, LoQ = 3.34 g/L, Linearity 0-60.2 g/L. Measuring Range: 4.6 to 56 g/L (up to 112 g/L with post-dilution) |
| Precision (Within-Run CV) | Single Site: Low: 3.3%, Mid: 1.0%, High: 0.5% (Sample 1, 3, 5) | Single Site: Low: 0.7%, Mid: 0.4%, High: 0.4% (Sample L, M, H) |
| Multi Site: Low: 2.7%, Mid: 1.3%, High: 2.0% (Sample 1, 3, 5 - listed as Within-Day) | Multi Site: Low: 2.2%, Mid: 1.4%, High: 0.6% (Sample 1, 2, 3 - listed as Within-Day) | |
| Precision (Total CV) | Single Site: Low: 7.2%, Mid: 6.8%, High: 2.5% (Sample 1, 3, 5) | Single Site: Low: 3.3%, Mid: 2.3%, High: 2.1% (Sample L, M, H) |
| Multi Site: Low: 3.9%, Mid: 2.5%, High: 3.6% (Sample 1, 3, 5) | Multi Site: Low: 3.4%, Mid: 1.8%, High: 0.8% (Sample 1, 2, 3) | |
| Interferences (Analyte values not showing >10% interference) | Hemoglobin: 500 mg/dL, Triglycerides: 504.88 mg/dL, Total Bilirubin: 28.84 mg/dL, Direct Bilirubin: 26.36 mg/dL, Acetylsalicylic Acid: 65.16 mg/dL, Ascorbic Acid: 5.98 mg/dL, Ibuprofen: 50.10 mg/dL, Acetaminophen: 20 mg/dL | Hemoglobin: 375 mg/dL, Triglycerides: 463.75 mg/dL, Total Bilirubin: 31.39 mg/dL, Direct Bilirubin: 26.27 mg/dL, Acetylsalicylic Acid: 65.16 mg/dL, Ascorbic Acid: 5.98 mg/dL, Ibuprofen: 50.10 mg/dL, Acetaminophen: 20 mg/dL |
| Method Comparison (with predicate device) | N=165 serum samples. Intercept: +3.907, Slope: 0.940, Correlation R²: 0.993 (against COBAS INTEGRA systems ALP IFCC Gen.2) | N=111 serum samples. Intercept: +0.421, Slope: 0.963, Correlation R²: 0.990 (against ABX Pentra 400 ABX Pentra Albumin CP) |
| Matrix Comparison (Plasma vs. Serum) | N=40 lithium-heparin plasma samples. Intercept: 0.3709, Slope: +1.013, Correlation: 0.993 (against Cobas800 with c502 module) | N=70 lithium-heparin plasma samples. Intercept: 0.769, Slope: +1.009, Correlation: 0.988 (against Pentra C400) |
| Reagent Stability | Closed: 15 months (2-8°C). On-board: 1 week | Closed: 24 months (2-8°C). On-board: 6 weeks |
| Reference Range | Verified against literature and limited study. Adults (Men: 40-129 U/L, Women: 35-104 U/L). Children data from literature. | Verified against literature and limited study. Adults: 35-52 g/L. Children data from literature. |
Study Details:
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Sample Size Used for the Test Set and Data Provenance:
- Yumizen C1200 ALP:
- Measuring Range/Linearity: Data not explicitly stated for individual samples, but the study showed linearity from 0 to 1620 U/L.
- Precision: "Single site: 20x2x2" and "Multi site: 3x5x2x3". This notation often refers to runs x replicates x instrument/lots, but the exact number of unique "samples" (control and general) for precision is stated as N=240 for single site, and N=90 for multi-site across various levels (control and patient samples). The provenance of these samples is not specified (e.g., country of origin) but they are "control" or "patient" samples. It's an analytical performance study, not a clinical study on specific patient populations.
- Interferences: Specific sample numbers for this study are not provided, but the tested interferent concentrations are listed.
- Method Comparison: 165 native serum samples.
- Matrix Comparison: 40 lithium-heparin plasma samples (individual donors).
- Yumizen C1200 Albumin:
- Measuring Range/Linearity: Data not explicitly stated for individual samples, but the study showed linearity from 0 to 60.2 g/L.
- Precision: "Single site: 20x2x2" and "Multi site: 3x5x2x3". Again, N=240 for single site and N=90 for multi-site across various levels.
- Interferences: Specific sample numbers for this study are not provided.
- Method Comparison: 111 native serum samples.
- Matrix Comparison: 70 lithium-heparin plasma samples (individual donors).
- Data Provenance: The document does not specify the country of origin for the samples. The studies are described as analytical performance validations, which are typically retrospective using banked/collected samples. The term "native serum samples" and "individual donors" implies real patient samples.
- Yumizen C1200 ALP:
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is an in vitro diagnostic device (measurement of lab analytes), not an imaging AI or diagnostic AI device where human experts establish "ground truth" in the typical sense of clinical interpretation.
- The ground truth for the test set is established by the predicate devices (Roche Diagnostics ALP IFCC Gen2 on COBAS INTEGRA systems, and HORIBA ABX SAS ABX Pentra Albumin CP on ABX Pentra 400/Pentra C400) or by established analytical methods for measuring concentrations (e.g., gravimetric for linearity, standard additions for LoD/LoQ).
- The "experts" involved are likely laboratory professionals, biochemists, and statisticians who design and execute these analytical validation studies according to CLSI (Clinical and Laboratory Standards Institute) guidelines. Their specific qualifications (e.g., MD, PhD) or number are not explicitly stated in this document but are assumed to be standard for medical device development.
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Adjudication Method for the Test Set:
- Not applicable in the context of analytical performance studies of laboratory reagents. Adjudication (e.g., 2+1, 3+1 consensus) is typical for clinical studies involving subjective interpretations (e.g., radiology reads). For a quantitative IVD, the "truth" is the measured value from a reference method or known concentration.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging interpretation or other scenarios where human readers make subjective judgments, and AI provides assistance. This document is for quantitative lab reagents, where the assessment is about the accuracy and precision of the measurement itself.
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If a Standalone Performance Study Was Done:
- Yes, the entire document describes standalone performance of the Yumizen C1200 ALP and Albumin reagents on the Yumizen C1200 analyzer. This is not an "algorithm only without human-in-the-loop" performance as the device itself is an integrated system of reagent, instrument, and software. "Standalone" in this context means the performance of the new device/reagent system as a complete unit, not in comparison to human interpretation.
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The Type of Ground Truth Used:
- External Reference Measurement: For method comparison studies, the "ground truth" is the result obtained from the legally marketed predicate device (Roche Diagnostics ALP IFCC Gen2 for ALP, and HORIBA ABX SAS ABX Pentra Albumin CP for Albumin).
- Known Concentrations/Standards: For linearity, limit of detection/quantitation, and interference studies, the ground truth is established by preparing samples with known concentrations of analytes and/or interferents.
- Consensus/Literature: For reference ranges, the ground truth is based on established bibliographic references and a verification study using "normal samples" from a blood bank.
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The Sample Size for the Training Set:
- This document describes the validation/test phase for regulatory submission (510(k)). It does not detail the training set used for the development of the reagents or the analyzer's measurement algorithms. For IVDs, the "training" analogous to machine learning often involves extensive R&D, chemical optimization, and instrument calibration development using a variety of samples, but these are not explicitly quantified in terms of a "training set" size in this regulatory summary.
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How the Ground Truth for the Training Set Was Established:
- As above, details about the "training set" are not provided. However, for the development of quantitative IVD assays, ground truth for initial development/training would typically be established through:
- Primary Reference Methods: Highly accurate and precise methods (e.g., isotope-dilution mass spectrometry) for specific analytes, often used for calibrator assignment.
- Certified Reference Materials: Materials with an assigned value and uncertainty for an analyte, traceable to recognized metrological standards.
- Large Sample Cohorts: A diverse range of clinical samples (with values determined by established methods) to ensure robustness across different patient populations and disease states.
- Experimental Design: Controlled experiments to characterize reagent stability, reaction kinetics, and potential interferents.
- As above, details about the "training set" are not provided. However, for the development of quantitative IVD assays, ground truth for initial development/training would typically be established through:
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.