Search Results
Found 1 results
510(k) Data Aggregation
(69 days)
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System.
BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma.
This reagent set is intended for in vitro diagnostic use only.
The Teco CX3 Reagent Set for SYSNCHRON CX designed for use on the Beckman CX System. The Reagent Set includes BUN, Calcium, Creatinine and Glucose.
The provided text describes the acceptance criteria and performance of the "Teco CX3 Reagent Set for SYNCHRON CX System" for the quantitative determination of BUN, Calcium, Creatinine, and Glucose in serum. The study is a method comparison and precision evaluation against predicate devices, following NCCLS guidelines. It is a standalone performance study of a diagnostic reagent set.
Here's the breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Feature/Analyte | Acceptance Criteria (Candidate Device) | Reported Device Performance (Teco CX3 Reagent Set) |
|---|---|---|
| BUN | Precision: CV% within 8% | Within-Day CV%: Sample 1: 2.5%, Sample 2: 1.9%, Sample 3: 1.3% |
| Day to Day CV%: Sample 1: 2.0%, Sample 2: 2.0%, Sample 3: 1.1% | ||
| Accuracy: r > 0.95; Slope: 0.97-1.1 | Accuracy: R=0.99, Y=1.00-0.911 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 3 to 102 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 15-39 mg/dL | |
| Calcium | Precision: CV% within 5% | Within-Day CV%: Sample 1: 0.9%, Sample 2: 0.9%, Sample 3: 0.8% |
| Day to Day CV%: Sample 1: 1.0%, Sample 2: 1.1%, Sample 3: 1.0% | ||
| Accuracy: r > 0.90; Slope: 0.90-1.1 | Accuracy: R=0.96, Y=1.07X+0.60 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 1.0 to 15 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 8.4-10.2 mg/dL | |
| Creatinine | Precision: CV% within 10% | Within-Day CV%: Sample 1: 2.7%, Sample 2: 1.6%, Sample 3: 1.7% |
| Day to Day CV%: Sample 1: 2.2%, Sample 2: 3.7%, Sample 3: 1.6% | ||
| Accuracy: r > 0.96; Slope: 0.90-1.1 | Accuracy: R=0.99, Y=0.97-0.11 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 0.2 to 24 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 0.6-1.3 mg/dL | |
| Glucose | Precision: CV% within 10% | Within-Day CV%: Sample 1: 2.5%, Sample 2: 1.3%, Sample 3: 1.5% |
| Day to Day CV%: Sample 1: 3.3%, Sample 2: 2.2%, Sample 3: 1.2% | ||
| Accuracy: r > 0.90; Slope: 0.85-1.1 | Accuracy: R=0.99, Y=0.96X+0.36 | |
| Linearity: Not explicitly stated as acceptance criteria, but reported. | Linearity: 30 to 750 mg/dL | |
| Expected Values/Reference Range: Not explicitly stated as acceptance criteria, but reported. | Expected Values/Reference Range: 70-105 mg/dL |
2. Sample size used for the test set and the data provenance
- Sample Size for Precision (Test Set): For the candidate device, N=25 for each of the three samples tested for within-day and day-to-day precision for BUN, Calcium, Creatinine, and Glucose.
- Sample Size for Accuracy/Linearity (Test Set): Not explicitly stated as a separate sample size for accuracy/linearity, but these tests typically use a series of patient samples and/or spiked samples. The "Method Comparison and Bias Estimation Using Patient Samples" (NCCLS EP9-A2) guideline was followed, indicating the use of patient samples.
- Data Provenance: The study used "Human Serum". The country of origin for the data is not specified in the provided text. It is a retrospective evaluation of the performance of the reagent set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a chemical assay study for quantitative determination of analytes. The "ground truth" is established by the analytical method itself and comparison to a predicate device. There is no mention of human experts interpreting results to establish ground truth in the context of this study.
4. Adjudication method for the test set
Not applicable. This is a quantitative chemical assay comparison, not an imaging or qualitative diagnostic study requiring 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 a study of an in vitro diagnostic reagent set, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Teco CX3 Reagent Set for SYNCHRON CX System" is a standalone diagnostic reagent set designed for use on an automated analyzer (Beckman CX3 System). Its performance (precision, linearity, accuracy) was evaluated independently of human interpretation of the results, beyond the standard operation of the analytical system.
7. The type of ground truth used
The ground truth is established by:
- Predicate Device Comparison: The candidate device's performance is compared against legally marketed predicate devices (Teco BUN Liquid, Teco Calcium Color, Teco Creatinine, and Teco Glucose Liquid Reagent).
- Analytical Standards: Linearity and accuracy are typically assessed against known concentrations of calibrators or reference materials.
- Statistical Analysis: Precision is measured through statistical analysis of replicate measurements.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI algorithm, and therefore there is no "training set" in the conventional sense. The development of the reagent set would involve internal validation and formulation, but these are not referred to as a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device. The formulation and quality control of the reagents during manufacturing would ensure their performance, but this is a different concept from establishing ground truth for a machine learning model.
Ask a specific question about this device
Page 1 of 1