(79 days)
The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.
The HCL-200 is an automated discrete random access in vitro diagnostic multichannel chemistry analyzer. It is composed of two modules:
- The liquid handling system includes compartments of reagents and samples as well as the pipetting unit.
- The reaction module includes the cuvette turntable to which samples and reagents are transferred. A photometer to monitor reaction response is also contained in this unit.
Then analyzer is linked to a PC compatible computer which loads software into each of the two modules.
This document describes the performance of the HCL-200 Clinical Chemistry Analyzer, not an AI device. Therefore, many of the requested fields are not applicable.
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Acceptance Criteria and Reported Device Performance
The HCL-200 Clinical Chemistry Analyzer's performance was evaluated against the predicate device, the Roche COBAS MIRA, using NCCLS (National Committee for Clinical Laboratory Standards) evaluation protocols. The acceptance criteria were not explicitly stated as numerical targets in the provided text. Instead, the study aimed to demonstrate "substantially equivalent performance" to the predicate device. This equivalence was assessed through linearity, precision (simple and complex), and method comparison studies.
The tables below summarize the reported device performance for each evaluated reagent, which served as evidence for meeting the implicit acceptance criteria of substantial equivalence.
Table 1: HCL-200 Reported Linearity & Precision
| REAGENT NAME | LINEARITY (Linear Range) | SIMPLE PRECISION (Normal CV / Abnormal CV) | COMPLEX PRECISION (Normal CV / Abnormal CV) |
|---|---|---|---|
| Albumin | 2 to 8.5 g/dL | 1.8% / 1.7% | 8% / 6.4% |
| ALT (GPT) | 0 to 650 U/L | 3% / 1.5% | 4.6% / 2.1% |
| Amylase | 0 to 2500 U/L | 4.6% / 1.7% | 5.0% / 3.5% |
| AST (GOT) | 0 to 650 U/L | 3.5% / 2.6% | 6.1% / 4.6% |
| Bilirubin, Total | 0 to 20 mg/dL | 2.8% / 1.5% | 7.3% / 9.0% |
| BUN, Rate | 0 to 125 mg/dL | 4.1% / 1.9% | 5.8% / 5.2% |
| CK NAD, Imidazole | 0 to 2100 U/L | 2.3% / 2.3% | 4.6% / 2.1% |
| Creatinine, (Jaffe) | 0 to 12.5 mg/dL | 2.45% / 1.9% | 7.2% / 3.1% |
| CRP | not applicable | 6.3% / 1.9% | 6.7% / 2.6% |
| GGT | 5 to 129 mg/dL | 2.9% / 1.3% | 5.9% / 2.2% |
| Glucose, Hexokinase UV | 0 to 600 mg/dL | 2.6% / 2.3% | 1.0% / 2.9% |
| LDH-L | 0 to 1000 U/L | 2.1% / 0.5% | 2.8% / 1.9% |
| Phosphorus | 0 to 15.0 mg/dL | 2.9% / 1.2% | 5.5% / 3.1% |
| Total Protein | 0 to 12 g/dL | 1.6% / 0.9% | 2.4% / 1.9% |
| Triglycerides GPO | 0 to 1000 mg/dL | 2.8% / 1.6% | 4.2% / 3.3% |
| Uric Acid | 0 to 20 mg/dL | 1.7% / 1.8% | 4.2% / 4.8% |
Table 2: HCL-200 Comparison to Predicate Device (COBAS MIRA)
| REAGENT NAME | COMPARISON TO PREDICATE (COBAS MIRA) |
|---|---|
| Albumin | N: 100, Slope [m]: 1.000, Intercept [b]: -0.03, Correlation Coeff. [r]: 0.987 |
| ALT (GPT) | N: 104, Slope [m]: 1.08, Intercept [b]: 0.6, Correlation Coeff. [r]: 0.998 |
| Amylase | N: 101, Slope [m]: 1.09, Intercept [b]: -2.8, Correlation Coeff. [r]: 0.999 |
| AST (GOT) | N: 100, Slope [m]: 1.05, Intercept [b]: -0.6, Correlation Coeff. [r]: 0.997 |
| Bilirubin, Total | N: 100, Slope [m]: 0.902, Intercept [b]: 0.11, Correlation Coeff. [r]: 0.993 |
| BUN, Rate | N: 100, Slope [m]: 0.948, Intercept [b]: 1.1, Correlation Coeff. [r]: 0.996 |
| CK NAD, Imidazole | N: 100, Slope [m]: 1.034, Intercept [b]: 5.6, Correlation Coeff. [r]: 0.999 |
| Creatinine, (Jaffe) | N: 103, Slope [m]: 0.994, Intercept [b]: 0.045, Correlation Coeff. [r]: 0.997 |
| CRP | N: 100, Slope [m]: Not specified, Intercept [b]: Not specified, Correlation Coeff: [r]: 0.992 |
| GGT | N: 100, Slope [m]: 1.07, Intercept [b]: -0.9, Correlation Coeff: [r]: 0.999 |
| Glucose, Hexokinase UV | N: 400, Slope [m]: 0.998, Intercept [b]: 7.5, Correlation Coeff: [r]: 0.992 |
| LDH-L | N: 100, Slope [m]: 1.06, Intercept [b]: 16.2, Correlation Coeff: [r]: 0.992 |
| Phosphorus | N: 111, Slope [m]: 1.06, Intercept [b]: 0.0, Correlation Coeff: [r]: 0.985 |
| Total Protein | N: 102, Slope [m]: 1.05, Intercept [b]: -0.09, Correlation Coeff: [r]: 0.983 |
| Triglycerides GPO | N: 102, Slope [m]: 1.025, Intercept [b]: -2.5, Correlation Coeff: [r]: 0.994 |
| Uric Acid | N: 100, Slope [m]: 1.02, Intercept [b]: -0.25, Correlation Coeff: [r]: 0.987 |
Study Details:
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Sample size used for the test set and the data provenance:
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Linearity (Number [N]):
- Albumin: 5
- ALT (GPT): 7
- Amylase: 9
- AST (GOT): 6
- Bilirubin, Total: 6
- BUN, Rate: 5
- CK NAD, Imidazole: 8
- Creatinine, (Jaffe): 5
- CRP: Not specified
- GGT: 8
- Glucose, Hexokinase UV: 5
- LDH-L: 9
- Phosphorus: 6
- Total Protein: 5
- Triglycerides GPO: 5
- Uric Acid: 5
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Simple Precision (Number [N]): 20 for all reagents.
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Complex Precision (Number [N]): 80 for all reagents.
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Comparison to Predicate (Number [N]):
- Albumin: 100
- ALT (GPT): 104
- Amylase: 101
- AST (GOT): 100
- Bilirubin, Total: 100
- BUN, Rate: 100
- CK NAD, Imidazole: 100
- Creatinine, (Jaffe): 103
- CRP: 100
- GGT: 100
- Glucose, Hexokinase UV: 400
- LDH-L: 100
- Phosphorus: 111
- Total Protein: 102
- Triglycerides GPO: 102
- Uric Acid: 100
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Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). However, the tests were conducted according to NCCLS evaluation protocols commonly used for in vitro diagnostic devices. This implies lab-based testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study concerns a chemical analyzer, not an AI device relying on expert interpretation of images or clinical data. The "ground truth" for these tests would be the established reference methods of the predicate device (COBAS MIRA) and calibrated controls/standards used in analytical chemistry.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is a measurement device, not an AI system requiring human adjudication of its output.
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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 not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The HCL-200 is a "discrete random access in vitro diagnostic multichannel chemistry analyzer." The performance reported is that of the instrument itself (standalone performance) under laboratory control. There is no human-in-the-loop for the analytical process of measuring chemical concentrations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is established clinical chemistry standards, controls, and comparisons to a legally marketed predicate device (Roche COBAS MIRA). The predicate device's measurements serve as the reference standard against which the HCL-200's results are compared.
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "training" in this context refers to optimizing application parameters for the reagents on the instrument after a "two-week device familiarization period." This is more akin to calibration and method development.
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How the ground truth for the training set was established: Not applicable, as there's no traditional "training set" for AI. The process described is "Preliminary evaluations using NCCLS EP 10 - T2 were run on each reagent in order to optimize application parameters." This involves using laboratory standards and controls to ensure the instrument's methods are correctly set up and calibrated for each assay.
§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.