(66 days)
Reagents: For the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. Calibrator: For the calibration of Genzyme Cystatin C assay. For In Vitro Diagnostic Use.
Genzymc Cystatin C assay reagent is based on the sol particle turbidimetric immunoassay principle. It contains colloidal gold particles coated with anticystatin C specific polyclonal antibodies. The reaction between the particles and any cystatin C in samples results in the formation of agglutinates and an associated change in absorbance signal. The change in absorbance signal is proportional to the amount of cystatin C in the sample. Cystatin C concentration in the sample is determined by comparison with a standard curve. Genzyme Cystatin C calibrators consist of a bovine serum albumin liquid matrix with assigned concentrations of cystatin C. The calibrators are preserved with sodium azide and are ready to use.
The provided text describes a 510(k) summary for a medical device called "Genzyme Cystatin C Reagent and Calibrator." It details the device's intended use, comparison to a predicate device, and performance characteristics to establish substantial equivalence. However, it does not explicitly define "acceptance criteria" in a quantitative manner as typically expected in a scientific study. Instead, it refers to "Performance characteristics" and states that these "support a determination of substantial equivalence."
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" with specific thresholds for parameters like sensitivity, specificity, or accuracy. Instead, it indicates that the device's performance was compared to a legally marketed predicate device (Dade Behring N Latex Cystatin C). The "acceptance" is implicitly tied to demonstrating "comparable performance and accuracy, good correlation, and substantial equivalence" to the predicate device.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Analytical Limits and Sensitivity | Testing performed; data "support a determination of substantial equivalence." |
| Within-run and Total Precision (over 20 days) | Testing performed; data "support a determination of substantial equivalence." |
| Linearity | Testing performed; data "support a determination of substantial equivalence." |
| Reportable Range | Testing performed; data "support a determination of substantial equivalence." |
| Stability | Testing performed; data "support a determination of substantial equivalence." |
| Analytical Specificity | Testing performed; data "support a determination of substantial equivalence." |
| Interfering Substances | Testing performed; data "support a determination of substantial equivalence." |
| Matrix Comparison | Testing performed; data "support a determination of substantial equivalence." |
| Reference Range | Testing performed; data "support a determination of substantial equivalence." |
| Method comparison studies with clinical specimens: | "demonstrate comparable performance and accuracy, good correlation, and substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Method comparison studies performed with clinical specimens demonstrate comparable performance and accuracy, good correlation, and substantial equivalence." However:
- Sample size: The exact sample size for the test set (clinical specimens) used in the method comparison studies is not provided.
- Data provenance: The country of origin of the data is not specified. It can be inferred that the samples are human serum, heparinized plasma, and EDTA plasma, but whether they are retrospective or prospective is not stated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information is not applicable or not provided for this device. The device is an in vitro diagnostic (IVD) assay that quantifies cystatin C directly. The "ground truth" for method comparison studies in IVDs typically relies on the performance of a meticulously validated reference method or the predicate device itself, not on expert consensus from radiologists or similar clinical experts.
4. Adjudication Method for the Test Set
Since the "ground truth" is likely established by a reference method or the predicate assay itself, an adjudication method (like 2+1, 3+1) involving human experts is not applicable or not described for this type of IVD performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically performed for image-based diagnostic aids or interpretations where human readers are involved. This device is an automated in vitro diagnostic assay for quantitative measurement. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned in the document.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The Genzyme Cystatin C assay is designed as an automated, standalone diagnostic test. Its performance characteristics (precision, linearity, specificity, analytical sensitivity, etc.) are inherently "algorithm only" in the sense that the device directly measures the analyte without human interpretation loops at the point of result generation. The "method comparison studies" essentially serve as a standalone performance assessment against a predicate method.
However, the term "standalone study" often implies a comparison to a clinical outcome or gold standard in the absence of human interpretation. While the method comparison evaluates the device's inherent analytical performance, the document doesn't use the term "standalone study" in a way that suggests a separate evaluation against a clinical gold standard beyond comparing it to the predicate device.
7. Type of Ground Truth Used
The primary ground truth used for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Dade Behring N Latex Cystatin C). The method comparison studies compare the Genzyme Cystatin C assay with the results obtained from the predicate device on clinical specimens. There is no mention of pathology, outcomes data, or expert consensus in this context.
8. Sample Size for the Training Set
The document is a 510(k) summary for an IVD reagent and calibrator kit, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The device's underlying principle is a turbidimetric immunoassay, not a learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As mentioned in point 8, the concept of a "training set" is not applicable to this device.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.