(36 days)
The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum. For in vitro diagnostic use. For point of care use.
The CARESIDE Analyzer is a compact chemistry instrument that performs multiple discrete analyses on human whole blood, plasma, or serum samples. The CARESDIDE Analyzer is semi-automated: the only operator steps are the addition of the sample to the test cartridge and the insertion of the dosed cartridge into the instrument. The CARESIDE Analyzer automatically warms, separates, meters, dispenses, and incubates the sample before reading the signal and calculating results. The CARESIDE Analyzer is intended only for use with CARESIDE test cartridges. The instrument is controlled through a touch-screen interface. Results are displayed on the interface screen. Results can also be downloaded on to a 3-1/2 inch diskette or to a computer via a RS-232 port. The CARESIDE Analyzer accepts up to 6 test cartridges from a single patient at the same time.
The provided text describes the CARESIDE™ Analyzer, an in vitro diagnostic instrument for measuring clinical chemistry analytes. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance (510(k)), rather than presenting a detailed study proving performance against explicit acceptance criteria.
However, based on the information provided, we can infer the approach taken for performance evaluation and how "acceptance criteria" are implied through comparison with a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in the format requested (e.g., "Accuracy must be within X% of reference method"). Instead, it relies on demonstrating substantial equivalence to an existing legally marketed predicate device (the Vitros DT 60/DTSC/DTE II Module and their own previously cleared CARESIDE Analyzer for lab use).
For each analyte the CARESIDE Analyzer measures, its performance would have been compared to the predicate device. The general "acceptance criteria" for regulatory clearance in this context are that the new device's performance is equivalent or better than the predicate device for its intended use, without raising new questions of safety or effectiveness.
While specific percentage differences or statistical thresholds are not given in this summary, the "Comparative Performance Characteristics" section states: "The clinical data provided demonstrate that the CARESIDE Analyzer... performs equivalently or better than the other legally marketed predicate device." This implies that for each analyte, the observed agreement, correlation, bias, and precision met the FDA's criteria for substantial equivalence when compared to existing devices.
To illustrate how such a table would be structured if explicit criteria were available, and how the performance statement translates, let's use a hypothetical example for a single analyte (e.g., Glucose) and infer the comparison:
| Acceptance Criteria Category | Specific Acceptance Criterion (Inferred from Substantial Equivalence to Predicate) | Reported Device Performance (Implied from Summary) |
|---|---|---|
| Accuracy (Correlation) | Correlation coefficient (R) vs. Predicate Device ≥ 0.95 (Hypothetical) | "Equivalent or better" than Predicate Device |
| Accuracy (Bias) | Mean bias vs. Predicate Device ≤ X% (Hypothetical) | "Equivalent or better" than Predicate Device |
| Precision (CV%) | %CV ≤ Y% for specified concentration ranges (Hypothetical) | "Equivalent or better" than Predicate Device |
| Measurement Range | Analytical Measuring Range (AMR) similar to Predicate Device | Similar to Predicate Device |
| Interferences | No significant interference at physiological levels (Hypothetical) | Comparable to Predicate Device |
The document points out that details for each individual test's 510(k) submission would contain the specific performance data ("see individual test 510k submissions").
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "clinical data provided" without further detail. This information would typically be found in the specific validation studies submitted with each individual test cartridge's 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a clinical chemistry analyzer, the "ground truth" for the test set would typically be established by comparison to a recognized reference method or a predicate device, as opposed to expert consensus on images or clinical assessments. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth is not directly applicable in the same way it would be for, say, an AI-powered diagnostic imaging device.
For a clinical chemistry analyzer, consistency and agreement with a predicate device or a gold standard laboratory method are the primary measures of ground truth. The "experts" involved would be clinical chemists, laboratory scientists, or medical technologists who perform the reference measurements and analyze the results. Their qualifications would include relevant certifications and experience in clinical laboratory testing.
4. Adjudication Method for the Test Set
As the ground truth is established by quantitative comparison to reference methods or a predicate device, an "adjudication method" in the sense of a committee resolving disagreements (e.g., 2+1, 3+1) is not typically used for clinical chemistry results. The differences between the new device and the reference/predicate would be analyzed statistically to determine agreement, bias, and correlation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. MRMC studies are typically used to evaluate the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, particularly in fields like radiology or pathology where human interpretation is central. The CARESIDE Analyzer is a standalone instrument that provides quantitative measurements, not an aid designed to improve human reader performance in interpreting complex data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the information provided describes the performance of the CARESIDE Analyzer as a standalone device. The instrument performs the measurement and calculation of results directly from the sample without human interpretation of raw signals. The comparison in the submission (as inferred) is between the measurements obtained by the CARESIDE Analyzer and those obtained by predicate devices or reference methods.
7. The Type of Ground Truth Used
The ground truth used for validating the CARESIDE Analyzer's performance would primarily be:
- Reference Methods: Measurements obtained from established, accurate laboratory methods (e.g., spectrophotometry, chromatography, highly accurate ion-selective electrodes) in a qualified clinical laboratory.
- Predicate Device Data: Performance data obtained from the legally marketed predicate device (Vitros DT 60/DTSC/DTE II Module and the CARESIDE Analyzer for lab use) on the same samples.
The document states that the individual test (analyte) cartridges were subject to separate 510(k) submissions, and those submissions would contain the detailed ground truth information for each specific analyte.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. The CARESIDE Analyzer is factory-calibrated, and lot-specific calibration coefficients are provided via barcodes on the cartridges. This implies that extensive calibration and characterization data (which could be considered a form of "training data" for the internal algorithms/calibration curves) were collected by the manufacturer during development and manufacturing. However, the exact sample sizes for this internal development and calibration are not disclosed in this regulatory summary.
9. How the Ground Truth for the Training Set was Established
The ground truth for establishing the factory calibration (which is analogous to the "training set" for the device's inherent algorithms) would typically involve:
- Certified Reference Materials (CRMs) or Standard Solutions: Samples with known, highly accurate concentrations of analytes.
- Split Sample Analysis: Running samples on both the CARESIDE system and established reference methods (or predicate devices) in a robust laboratory setting to generate the dose-response curves and calibration coefficients.
- Statistical Modeling: Using the data from CRMs and split samples to derive the polynomial equations that convert raw reflectance/potentiometry signals into analyte concentrations.
The document mentions that "The observed reflectance (ODr) is adjusted by inputting it into the equation. The patient result is calculated from the adjusted ODr using the polynomial describing the master dose - response curve." This "master dose-response curve" and its associated polynomial are derived from this extensive calibration process using samples with established ground truth. This process ensures the instrument correctly interprets its raw signals into clinically meaningful concentrations across its analytical measuring range.
§ 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.