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510(k) Data Aggregation
(414 days)
Creatinine Enzymatic Reagent Kit is a device which is intended for measurement of creatinine level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status of kidney function and the diagnosis of renal diseases, and also serve as a component of several calculations for determination of creatinine clearance or glomerular filtration rate (GFR).
Creatinine Enzymatic Reagent Kit is a dual reagent one contains Good's buffer, creatine amidinohydrolase, sarcosine oxidase and ESPMT (3-(N-Ethyl-3methylanilino) propanesulfonic acid sodium salt). Reagent two contains Good's buffer, creatinine amidohydrolase, Peroxidase and 4-aminoantipyrine.
The provided text describes the performance characteristics and acceptance criteria for the Teco Creatinine Enzymatic Reagent Kit, but it does not detail a study involving human readers or AI assistance. The device is a diagnostic test kit, not an AI-powered diagnostic system requiring human interpretation.
Therefore, questions related to human reader performance, AI assistance, multi-reader multi-case studies, and human interpretation of ground truth are not applicable to this document. The information provided focuses solely on the analytical performance of the diagnostic reagent kit.
Here's the breakdown of the information that is applicable from your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list acceptance criteria in a dedicated table, but it presents performance data against established guidelines (CLSI standards) and compares it to a predicate device. The "acceptance criteria" are implied by meeting CLSI standards and demonstrating comparable performance to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Teco Creatinine Enzymatic Reagent Kit) |
|---|---|---|
| Intended Use | Quantitative determination of creatinine in human serum | Quantitative determination of creatinine in human serum |
| Specimen | Serum | Serum |
| Methodology | Enzymatic | Enzymatic |
| Linearity (Measuring Range) | Comparable to predicate (0.04 to 5.1 mg/dL for serum) | 0.37 - 5.06 mg/dL |
| Correlation (R²) | High correlation with predicate (R closer to 1.0) | R² = 0.9986 (compared to predicate) |
| Storage | 2-8 °C | 2-8 °C |
| Intra-assay Repeatability | Low CV% (e.g., < 2%) | Patient Pool 1: 0.93% CV; Patient Pool 2: 0.87% CV; Patient Pool 3: 0.90% CV |
| Within-Laboratory Precision | Low CV% (e.g., < 3%) | Patient Pool 1: 1.98% CV; Patient Pool 2: 2.18% CV; Patient Pool 3: 1.08% CV |
| Limit Of Blank (LoB) | Low (ideally 0.00 mg/dL) | 0.00 mg/dL |
| Limit Of Detection (LoD) | Low (e.g., < 0.05 mg/dL) | 0.01 mg/dL |
| Limit Of Quantitation (LoQ) | Low (e.g., < 0.1 mg/dL) with CV% < 20% | 0.10 mg/dL (with accuracy goal of CV < 20%) |
| Analytical Specificity | Minimal interference from common substances | Most substances (<10% interference); list of interfering substances provided (e.g., conjugated bilirubin at 24.95 mg/dL, triglycerides at 3000 mg/dL) |
| Reference Interval | Verified against established ranges (Larsen K., 1972) | Men: 0.9-1.5 mg/dL; Women: 0.7-1.4 mg/dL |
2. Sample size used for the test set and the data provenance
- Precision/Reproducibility:
- Sample Size: Three serum pools. For intra-assay precision, each of the three pools was assayed for 20 operating days, twice per day, in triplicates (3 pools * 20 days * 2 runs/day * 3 replicates/run = 360 measurements per pool per reagent lot, for two reagent lots).
- Data Provenance: "Patient serum pools" are mentioned. The specific country of origin is not stated, but the company is US-based (Anaheim, CA), suggesting data may be from the US or procured globally for clinical lab use. The studies are prospective in nature, as they involve actively "assaying samples."
- Linearity/Assay Reportable Range:
- Sample Size: Eleven samples, assayed in duplicates for each reagent lot.
- Data Provenance: "Patient serum pools." Prospective.
- Detection Limit (LoB, LoD, LoQ):
- LoB: Four diluted real pooled serum samples. Fifteen replicates for each sample, using two reagent lots (4 samples * 15 replicates * 2 lots = 120 measurements).
- LoD: Four diluted serum samples (100x, 50x, 33x, 25x). Fifteen times for each sample (4 samples * 15 replicates = 60 measurements).
- LoQ: Four low concentration samples from native serum sample pools. Fifteen times each (4 samples * 15 replicates = 60 measurements).
- Data Provenance: "real pooled serum samples," "native serum sample pools." Prospective.
- Analytical Specificity:
- Sample Size: Samples with increasing amounts of potential interferents were tested in triplicate. Two different clinically relevant concentrations of creatinine (1.50 and 5.00 mg/dL) were used. The number of interferents tested is listed as 15. So, for each interferent, at least (2 creatinine conc * X interferent conc * 3 replicates) measurements were done.
- Data Provenance: Not specified, but likely controlled laboratory samples. Prospective.
- Method Comparison:
- Sample Size: 98 serum samples.
- Data Provenance: "Serum samples." Not explicitly stated if patient samples or contrived. Given the context of comparing to a predicate, historical patient samples are likely. The study is presented as a comparison, which implies a retrospective analysis against existing methods.
- Expected Values/Reference Interval:
- Sample Size: 20 healthy male donors and 20 healthy female donors (total 40 donors).
- Data Provenance: Human serum samples from healthy donors (age 20-65). Prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is a diagnostic reagent kit. "Ground truth" is established by the analytical method itself (e.g., reference method for method comparison studies, or a gold standard for traceability) and the physiological state of the samples (e.g., healthy donors, patient pools). There are no human experts interpreting images or signals to establish ground truth in the way described for AI/human-in-the-loop systems.
The creatinine calibrator values are traceable to NIST reference material (SRM 967), which serves as a metrological ground truth.
4. Adjudication method for the test set
Not applicable. This device does not involve human interpretation or adjudication for its results.
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. No human readers or AI assistance are involved with this diagnostic kit.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in a sense, the entire performance study is a "standalone" assessment of the reagent kit's analytical performance (analogous to an "algorithm only" performance for an AI system), as it measures the kit's ability to accurately quantify creatinine without human interpretative input influencing the result. The device is purely an in vitro diagnostic reagent kit.
7. The type of ground truth used
- Reference method/Predicate device: For method comparison, the "Stanbio Creatinine LiquiColor test system" serves as the comparative reference.
- NIST Reference Material (SRM 967): For traceability of calibrator values.
- CLSI guidelines: For various analytical performance characteristics (precision, linearity, detection limits, specificity).
- Established biological ranges/clinical literature: For expected values/reference intervals (e.g., "Larsen K. Clin Chem Acta 41:209, 1972").
- Known concentrations: For studies like linearity, detection limits, and analytical specificity, samples are prepared with known concentrations of analyte or interferents.
8. The sample size for the training set
Not applicable. This is a chemical reagent kit, not a machine learning model, so there is no concept of a "training set" in the context of data used for algorithm development. Its development would involve chemical optimization and formulation rather than data-driven training.
9. How the ground truth for the training set was established
Not applicable (no training set for this type of device).
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