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510(k) Data Aggregation
(55 days)
HICHEM TOTAL PROTEIN REAGENT
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
The HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems, and serum, plasma, and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. The study aimed to demonstrate its substantial equivalence to the SYNCHRON® CX® Systems Total Protein Reagent Kit (product no. 450224) manufactured by Beckman Coulter, Inc.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the comparison to a predicate device and established NCCLS guidelines for precision. While explicit numerical acceptance criteria are not stated as "acceptance criteria," the reported performance demonstrates equivalence, which is the underlying goal for 510(k) submission.
| Metric (Implied Acceptance Criterion: Comparable to Beckman® Reagent) | HiChem® Total Protein Reagent Performance | Beckman® Total Protein Reagent Performance (Predicate) | Discussion |
|---|---|---|---|
| Precision (Within Run %CV): | |||
| Serum 1 (3.8 g/dL) | 1.1% | 1.2% | Comparable |
| Serum 2 (5.9 g/dL) | 0.7% | 0.8% | Comparable |
| Serum 3 (8.0 g/dL) | 0.7% | 0.6% | Comparable |
| CSF 1 (21 mg/dL) | 15.2% | 5.2% | Higher for HiChem® |
| CSF 2 (53 mg/dL) | 3.1% | 2.8% | Comparable |
| Precision (Total %CV): | |||
| Serum 1 (3.8 g/dL) | 1.7% | 1.3% | Comparable |
| Serum 2 (5.9 g/dL) | 1.3% | 1.0% | Comparable |
| Serum 3 (8.0 g/dL) | 1.4% | 1.1% | Comparable |
| CSF 1 (21 mg/dL) | 19.7% | 12.2% | Higher for HiChem® |
| CSF 2 (53 mg/dL) | 4.4% | 5.2% | Comparable |
| Patient Comparison (Linear Regression for Serum/Plasma): | y = 0.2 + 0.970x | N/A (predicate comparison) | Strong correlation (r = 0.988) with the predicate. |
| Patient Comparison (Linear Regression for CSF): | y = -2.8 + 1.010x | N/A (predicate comparison) | Strong correlation (r = 0.995) with the predicate. |
Note: For the CSF 1 precision, the HiChem® reagent shows higher %CVs compared to the Beckman® reagent. However, the strong correlation in the patient comparison for CSF (r = 0.995) suggests that despite higher variability at lower concentrations, the overall agreement with the predicate is very high.
2. Sample Sizes and Data Provenance:
- Precision Test Set:
- Serum and Cerebrospinal Fluid Controls: Each control was assayed 3 times per day for 10 days, resulting in n=60 measurements for each sample (3 assays/day * 10 days * 2 reagents = 60 for HiChem®, 60 for Beckman®, for a total of 120 measurements per sample type).
- Data Provenance: Not explicitly stated, but assumed to be prospective, collected during the study. Country of origin is not specified.
- Patient Comparison Test Set:
- Serum/Plasma Specimens: n=160 adult patients.
- CSF Specimens: n=40 adult patients.
- Data Provenance: Retrospective, collected from adult patients. Country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device is an in vitro diagnostic reagent, and its performance is assessed against a predicate device and NCCLS guidelines, not against human expert interpretation or a "ground truth" established by experts in the typical sense of image analysis or diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable, as the "ground truth" is based on quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a device intended for human interpretation or a scenario where human readers would collaborate with AI.
6. Standalone (Algorithm Only) Performance:
Yes, the study presents the standalone performance of the HiChem® Total Protein Reagent. The precision and patient comparison studies demonstrate the reagent's performance in isolation, with measurements obtained directly from the SYNCHRON CX® DELTA System. There is no human-in-the-loop component in the evaluation of this reagent's analytical performance.
7. Type of Ground Truth Used:
The "ground truth" for this study is established by:
- Comparison to a legally marketed predicate device: The SYNCHRON® CX® Systems Total Protein Reagent Kit (product no. 450224) manufactured by Beckman Coulter, Inc. This implicitly serves as the standard for expected performance.
- Quantitative measurements: The accuracy of the reagent is assessed by its correlation with the predicate device using least squares linear regression.
- Internal precision: Assessed against NCCLS publication EP3-T guidelines, indicating repeatability and reproducibility.
8. Sample Size for the Training Set:
Not applicable. This is a chemical reagent, not an AI/ML algorithm that requires a training set. The performance is evaluated based on its chemical and analytical properties when run on a specified instrument.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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