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510(k) Data Aggregation
(175 days)
The Hitachi Clinical Analyzer with S TEST reagent cartridges for total cholesterol (CHO), HDL cholesterol (HDL), LDL cholesterol (LDL), and triglycerides (TG) is intended for the quantitative measurements of CHO, HDL, LDL, and TG in serum or heparinized plasma. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
- Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, and lipid and lipoprotein metabolism disorders.
- HDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- LDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.
The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).
System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or heparin plasma and results are available in approximately 15 minutes per test. This submission is for the Lipid Panel, consisting of reagent cartridges for total cholesterol, HDL, LDL, and triglycerides.
Here's a breakdown of the acceptance criteria and study information for the Hitachi Clinical Analyzer S TEST Reagent Cartridges, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as defined thresholds for all performance metrics. Instead, it presents the results of several performance studies (analytical sensitivity, linearity, precision, interference, and method comparison) which collectively demonstrate that the device performs comparably to the predicate devices and is suitable for its intended use. For this table, I will present the reported performance of the new device and, where available, compare it to the predicate device's listed performance as an implicit acceptance benchmark.
Hitachi Clinical Analyzer S TEST Reagent Cartridges Performance Summary
| Metric | Analyte | Acceptance Criteria (Implied by Predicate/Study Nature) | Reported Device Performance (Hitachi S TEST) |
|---|---|---|---|
| Analytical Sensitivity (Detection Limit) | CHO | Lower than or comparable to predicate (3.86 mg/dL) | 0.7 mg/dL |
| HDL | Lower than or comparable to predicate (3 mg/dL) | 0.6 mg/dL | |
| LDL | Lower than or comparable to predicate (3.86 mg/dL) | 0.8 mg/dL | |
| TG | Lower than or comparable to predicate (8.85 mg/dL) | 2.5 mg/dL | |
| Linearity | CHO | Comparable to predicate (3.86 to 800 mg/dL) | 1 to 435 mg/dL |
| HDL | Comparable to predicate (3 to 121 mg/dL) | 4 to 485 mg/dL | |
| LDL | Comparable to predicate (3.86 to 548 mg/dL) | 3 to 430 mg/dL | |
| TG | Comparable to predicate (8.85 to 885 mg/dL) | 2 to 848 mg/dL | |
| Precision (In-house total %CV) | CHO | Comparable to predicate (1.4% to 1.6%) | 1.5% to 1.8% |
| HDL | Comparable to predicate (0.9% to 1.5%) | 2.7% to 3.8% | |
| LDL | Comparable to predicate (1.9% to 2.7%) | 2.7% to 5.2% | |
| TG | Comparable to predicate (1.6% to 2.0%) | 2.4% to 5.6% | |
| Precision (POL total %CV) | CHO | Acceptable for POL use | 0.7% to 1.4% |
| HDL | Acceptable for POL use | 1.3% to 4.5% | |
| LDL | Acceptable for POL use | 1.3% to 2.0% | |
| TG | Acceptable for POL use | 1.1% to 4.1% | |
| Interference | All analytes | No significant interference from hemoglobin, bilirubin, lipemia, ascorbic acid at specified levels. | No interference up to stated levels (e.g., Hemoglobin: 1000 mg/dL for CHO/LDL, 500 mg/dL for HDL/TG; Bilirubin: 50 mg/dL for CHO/HDL/TG, 25 mg/dL for LDL; Lipemia: 2000 mg/dL for CHO, 725 mg/dL for HDL, 614 mg/dL for LDL; Ascorbic acid: 50 mg/dL for all). |
| Method Comparison (Correlation coefficient 'r') | CHO | High correlation with predicate (e.g., >0.95) | 0.996 (in-house), 0.97-0.99 (POL) |
| HDL | High correlation with predicate | 0.986 (in-house), 0.98-0.99 (POL) | |
| LDL | High correlation with predicate | 0.981 (in-house), 0.98-0.99 (POL) | |
| TG | High correlation with predicate | 0.998 (in-house), 0.99 (POL) | |
| Matrices Comparison | All analytes | High correlation between serum and heparinized plasma | Correlation coefficients (r) 0.999 for all |
2. Sample Sizes Used for the Test Set and Data Provenance
- Analytical Sensitivity (Limits of Detection): Not explicitly stated, but the studies followed CLSI EP17-A.
- Linearity: Not explicitly stated, but the studies followed CLSI EP-6A.
- 20-day In-house Precision:
- Test set/samples: 3 or 4 levels of samples per analyte.
- Number of replicates: Each level tested four times a day for 20 days (n=80 per level).
- Provenance: In-house.
- Interference Testing: Not explicitly stated, but followed CLSI EP7-A2.
- In-house Method Comparisons:
- Test set/samples: Minimum of 109 serum samples (CHO: 113, HDL: 109, LDL: 122, TG: 111).
- Provenance: Not explicitly stated, but implies samples prepared or collected for this in-house comparison.
- Matrices Comparisons:
- Test set/samples: Approximately 40 matched serum/plasma samples per analyte.
- Provenance: Not explicitly stated if collected specifically for the study, but implies prospective collection for matching.
- External POL Site Precision Study:
- Test set/samples: 3 blinded serum samples (low, intermediate, high concentrations) per site.
- Number of replicates: Each sample assayed six times per day for five days (n=30 replicates per sample per site).
- Provenance: External POL-type sites (implies various locations, prospective collection for the study).
- External POL Site Method Comparisons:
- Test set/samples: Approximately 50 blinded serum samples per POL site.
- Provenance: External POL-type sites and a central laboratory (implies samples collected for the study or from routine clinical practice).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For this type of device (in vitro diagnostic for chemical analysis), the "ground truth" is typically established by reference methods or predicate devices, not human experts in the way it would be for imaging diagnostics.
- In-house Method Comparisons: The predicate device (Roche/Hitachi cobas for individual analytes) served as the reference for comparison. The performance of these predicate devices in establishing "ground truth" is based on their own FDA clearances and established analytical validity.
- External POL Site Method Comparisons: The Roche cobas 6000 (predicate system) at a central laboratory served as the reference for comparison.
Therefore, the "ground truth" for these studies was established by measurements from legally marketed predicate devices, not by new human expert consensus.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense for a laboratory measurement device. The comparison is quantitative between the candidate device and a predicate device/reference method. Discrepancies would be analyzed statistically rather than by human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device for quantitative chemical analysis, not a diagnostic imaging or screening device that typically involves human "readers" interpreting "cases."
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, the studies presented (analytical sensitivity, linearity, precision, interference, and method comparisons) all represent the standalone performance of the Hitachi Clinical Analyzer with S TEST cartridges. The device is an automated, bench-top, wet chemistry system, meaning it functions without direct human intervention in the measurement process after sample loading and initiating the test.
7. Type of Ground Truth Used
The ground truth for the performance studies was established using measurements from legally marketed predicate devices (Roche/Hitachi cobas 6000, Roche/Hitachi test reagents, and Alfa Wasserman S40 system). For precision studies, it's about the device's own reproducibility against internal controls and known concentrations, not an external "ground truth" in the same way.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an AI/machine learning model. This is a traditional in vitro diagnostic device, not an AI-driven one. Its performance is characterized through analytical studies (sensitivity, linearity, precision, accuracy/method comparison, interference) using test samples, not through training data for a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as it's not an AI/ML device that requires a training set with established ground truth).
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