Search Results
Found 2 results
510(k) Data Aggregation
(28 days)
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
The Ammonia/Ethanol/CO2 Calibrator is a liquid ready-for-use calibrator based on a buffered aqueous solution. The concentration of the calibrator The Ammonia/Ethanol/CO2 Controls are liquid ready-for-use controls based on a buffered aqueous solution. The adjusted concentrations of the control components are in the normal range for the Normal control and the pathological range for the Abnormal control.
This document is a 510(k) summary for a medical device (Ammonia/Ethanol/CO2 Calibrator and Controls) and does not contain information typically found in a study proving a device meets acceptance criteria for an AI or software-based medical device.
The provided text describes a calibrator and controls for in vitro diagnostic devices, which are reagents used to ensure the accuracy and precision of laboratory tests on clinical chemistry analyzers. These are physical products, not software/AI, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test/training sets," "ground truth," "MRMC studies," or "standalone performance" as typically applied to AI/software devices are not directly applicable in the same way.
The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of product. Substantial equivalence means the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).
Here's a breakdown of the information in relation to your request, highlighting what's missing due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance:
This type of table is not present in the document because this is not a performance study of an AI/software device. For a calibrator/control, "performance" relates to its ability to accurately and precisely calibrate and control the analytical process of a clinical chemistry analyzer. The document states:
- Intended Use of Calibrator: "for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet."
- Intended Use of Control: "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet."
The "acceptance criteria" here would generally be related to the stability, homogeneity, and assigned values of the calibrator/control, and their ability to ensure the accuracy of the assay. These details are not within this summary. Substantial equivalence usually means that the new device performs similarly to the predicate in these aspects.
| Acceptance Criteria (Implied for Calibrator/Control) | Reported Device Performance (Implied from substantial equivalence claim) |
|---|---|
| Ability to accurately calibrate quantitative Roche methods | Substantially equivalent to predicate device (K952282) |
| Ability to monitor accuracy and precision for quantitative methods | Substantially equivalent to predicate device (K951595) |
| Performance characteristics (e.g., analyte concentrations, stability) | Equivalent to predicate devices (K952282 and K951595) |
Regarding items 2-9, these are generally not applicable to this type of device and submission:
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/software algorithm. The device itself is a physical calibrator/control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant here. The ground truth for the calibrator/control would be the analytically determined true values of the analytes within the product, established through reference methods or highly accurate assays, not expert consensus on images or similar data.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like diagnosis or detection.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For a calibrator/control, the "ground truth" refers to the assigned values or the true concentrations of the analytes (Ammonia, Ethanol, CO2) within the calibrator and control materials. This is typically established through a rigorous analytical process using reference methods and highly accurate instrumentation, not expert consensus, pathology, or outcomes data in the way these terms are used for AI/software devices.
8. The sample size for the training set: Not applicable. No training set for an AI/software algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary of what's provided for this type of device and submission:
- Device Name: Ammonia/Ethanol/CO2 Calibrator and Controls
- Intended Use: Calibration and quality control for quantitative Roche methods on Roche clinical chemistry analyzers.
- Predicate Device:
- Regulatory Conclusion: Substantial Equivalence to the predicate devices. This means the FDA has determined the new device is as safe and effective as the existing marketed devices. The "study that proves the device meets the acceptance criteria" in this context is the evidence presented by the manufacturer to the FDA demonstrating this substantial equivalence, which would include data on the formulation, stability, and characterization of the calibrator and controls, demonstrating they perform comparably to the predicate. These detailed data points are not typically included in the 510(k) Summary, but rather in the full 510(k) submission.
Ask a specific question about this device
(80 days)
The cassette Roche COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma. Determination of carbon dioxide concentration in blood is most commonly performed as an initial test in the cvaluation of the body's ability to control blood pH by appropriate removal of metabolism byproducts via the lung and kidneys.
The cassette Roche COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma, urine and cerebrospinal fluid (CSF). In addition, an optional glucose "fast application" for serum and plasma is available. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8℃. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
The provided text describes two devices, COBAS INTEGRA Carbon Dioxide (CO2-S) and COBAS INTEGRA Glucose HK Liquid (GLULF), in a 510(k) submission. Here's an analysis of the acceptance criteria and supporting studies for each:
Device 1: COBAS INTEGRA Carbon Dioxide (CO2-S)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria." However, substantial equivalence is determined by comparing the performance characteristics of the proposed device against a legally marketed predicate device. The values presented for the proposed device imply the performance achieved for each characteristic, and the aim is to demonstrate that these are equivalent to or better than the predicate.
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (CO2-S) |
|---|---|---|
| Assay Range | 0 - 40 mmol/L | 0 - 50 mmol/L |
| Sensitivity | $5.2 \times 10^{-2} \Delta A$ per mmol/L | $1.5 \times 10^{-2} \Delta A$ per mmol/L |
| Precision: | ||
| Level 1 Mean (mmol/L) | 18.9 | 19.5 |
| Level 2 Mean (mmol/L) | 33.0 | 33.8 |
| % CV (within-run) | Level 1: 1.2; Level 2: 1.1 | Level 1: 1.1; Level 2: 1.2 |
| % CV (total) | Level 1: 2.5; Level 2: 1.9 | Level 1: 3.1; Level 2: 2.5 |
| Accuracy: | ||
| Sample size (n) | 200 | 220 |
| Corr. Coefficient (r) | 0.997 | 0.999 |
| Linear Regression | 1.04x + 0.4 mmol/L | 1.01x - 0.8 mmol/L |
Note: The reported sensitivity for the proposed device (1.5 x 10^-2 ΔA per mmol/L) is lower than the predicate (5.2 x 10^-2 ΔA per mmol/L). In immunoassay terms, a lower ΔA indicates lower sensitivity, which could be a point of divergence. However, the FDA's clearance implies that the overall performance was deemed substantially equivalent, often considering the clinical impact and other strong performance metrics like accuracy and precision. The assay range of the proposed device is wider, which is generally an improvement. The precision and accuracy metrics are comparable or slightly better in some aspects for the proposed device.
2. Sample size used for the test set and the data provenance
- Sample size for accuracy test set (n): 220
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The document uses generic terms like "clinical and nonclinical studies." Given the context of a 510(k) submission to the US FDA, it's highly probable the data was collected under controlled conditions to support regulatory approval, likely in a prospective manner, but this is not explicitly confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an in vitro diagnostic device measuring a quantitative analyte. The "ground truth" (or reference values) for comparison are established by a reference method or legally marketed predicate device, not by expert interpretation of images or other qualitative data. Therefore, no experts were used in this manner.
4. Adjudication method for the test set
Not applicable for this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used for qualitative assessments, often in imaging studies where multiple readers interpret results and discrepancies need resolution. For quantitative measurements, comparisons are made against established reference methods or predicate devices.
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 not an AI/imaging device. It is an in vitro diagnostic reagent system for quantitative determination of a chemical analyte.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance characteristics provided (assay range, sensitivity, precision, accuracy) represent the standalone performance of the COBAS INTEGRA Carbon Dioxide (CO2-S) reagent on the COBAS INTEGRA Analyzer. This is typical for in vitro diagnostic devices where the analytical performance of the assay itself is validated.
7. The type of ground truth used
The ground truth for the analytical accuracy (correlation and linear regression) is based on comparison against a reference method or a predicate device. The linearity and correlation coefficients indicate how well the proposed device's measurements align with these established methods. The predicate device "COBAS INTEGRA Carbon Dioxide (CO2)" (K954992) serves as the primary comparator.
8. The sample size for the training set
Not provided. For in vitro diagnostic devices like this, there isn't typically a "training set" in the machine learning sense. Method development and optimization (which might be analogous to training) would involve various samples, but the specific number is not disclosed in the 510(k) summary, which focuses on validation/test data.
9. How the ground truth for the training set was established
Not applicable as there is no explicitly defined "training set" with ground truth in the traditional sense for this type of device in the provided document. Method development and optimization would use samples with known CO2 concentrations, but the specific process for establishing these values for internal development is not detailed.
Device 2: COBAS INTEGRA Glucose HK Liquid (GLULF) (fast application)
1. Table of Acceptance Criteria and Reported Device Performance
Similar to CO2-S, the document presents performance characteristics for the proposed GLULF "fast application" in comparison to its predicate (standard application).
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (GLULF - fast application) |
|---|---|---|
| Assay Range | 0 - 40 mmol/L | 0 - 30 mmol/L |
| Sensitivity | $5.4 \times 10^2 \Delta A$ per mmol/L | $5.4 \times 10^2 \Delta A$ per mmol/L |
| Precision: | ||
| Level 1 Mean (mmol/L) | 5.3 | 4.7 |
| Level 2 Mean (mmol/L) | 33.2 | 27.7 |
| % CV (within-run) | Level 1: 1.7; Level 2: 0.72 | Level 1: 1.4; Level 2: 0.5 |
| % CV (total) | Level 1: 2.6; Level 2: 1.5 | Level 1: 2.4; Level 2: 1.2 |
| Accuracy: | ||
| Sample size (n) | 220 | 216 |
| Corr. Coefficient (r) | 0.999 | 0.999 |
| Linear Regression | 1.05x - 0.2 mmol/L | 0.99x + 0.01 mmol/L |
Note: The reported assay range for the "fast application" is narrower (0-30 mmol/L) compared to the standard application (0-40 mmol/L). However, precision for the fast application appears slightly better (lower %CVs), and the sensitivity is identical. The accuracy metrics (correlation coefficient and linear regression) are highly comparable, indicating substantial equivalence in performance for the intended use and specified range.
2. Sample size used for the test set and the data provenance
- Sample size for accuracy test set (n): 216
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). Similar to CO2-S, the data would likely be from controlled studies, presumably prospective, but this is not explicitly confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an in vitro diagnostic device measuring a quantitative analyte. The "ground truth" for comparison is established by a reference method or legally marketed predicate device.
4. Adjudication method for the test set
Not applicable for this type of in vitro diagnostic device.
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 not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics provided represent the standalone analytical performance of the COBAS INTEGRA Glucose HK Liquid (GLULF) fast application reagent on the COBAS INTEGRA Analyzer.
7. The type of ground truth used
The ground truth for the analytical accuracy is based on comparison against a reference method (enzymatic reference method with hexokinase) or a predicate device (COBAS INTEGRA Glucose HK Liquid - standard application, K972250).
8. The sample size for the training set
Not provided. Similar to CO2-S, "training set" in the machine learning sense is not applicable or detailed in the document.
9. How the ground truth for the training set was established
Not applicable as there is no explicitly defined "training set" with ground truth in the traditional sense for this type of device in the provided document. Method development and optimization would use samples with known glucose concentrations, but the specific process for establishing these values for internal development is not detailed.
Ask a specific question about this device
Page 1 of 1