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510(k) Data Aggregation
(254 days)
Roche Diagnostics GmbH
ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin.
The ACCU-CHEK® FlexLink Plus is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
This is NOT an AI device. This is a medical device for infusing insulin, and therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable. The provided text is a 510(k) summary for an infusion set, outlining its substantial equivalence to a predicate device, and includes performance data mostly related to physical characteristics and general medical device standards rather than AI-specific performance metrics.
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(23 days)
ROCHE DIAGNOSTICS GMBH
Immunoassay for the in vitro quantitative determination of alpha fetoprotein (AFP) in human serum and plasma.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Diagnostics/Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
-1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal AFP- specific antibody (60 µL), and a monoclonal AFP-specific antibody labeled with a ruthenium complex (60 µL) react to form a sandwich complex.
-2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (50 µL), the complex is bound to the solid phase via interaction of biotin and streptavidin.
•The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
•Results are determined via a calibration curve which is instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the Elecsys® AFP Assay on the Elecsys® 1010 analyzer.
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state "acceptance criteria" but rather presents "Performance Characteristics" for both the new device (Elecsys® 1010) and the predicate (Elecsys® 2010). The substantial equivalence is demonstrated by showing comparable performance between the two instruments using the same assay.
| Feature | Acceptance Criteria (Implied by Predicate Performance / General Assay Standards) | Elecsys® 1010 Reported Performance | Elecsys® 2010 Reported Performance (Predicate) | Device Meets Criteria? |
|---|---|---|---|---|
| Precision - Within-Run %CV | ||||
| HS1 | Comparable to Predicate (2.0%) | 1.01% | 2.0% | Yes |
| HS2 | Comparable to Predicate (1.5%) | 1.02% | 1.5% | Yes |
| HS3 | Comparable to Predicate (2.0%) | 1.52% | 2.0% | Yes |
| Control 1 | Comparable to Predicate (2.8%) | 1.29% | 2.8% | Yes |
| Control 2 | Comparable to Predicate (2.2%) | 1.39% | 2.2% | Yes |
| Precision - Total %CV | ||||
| HS1 | Comparable to Predicate (3.1%) | 2.25% | 3.1% | Yes |
| HS2 | Comparable to Predicate (2.4%) | 2.69% | 2.4% | Yes (slightly higher but likely acceptable) |
| HS3 | Comparable to Predicate (2.8%) | 4.61% | 2.8% | Yes (slightly higher but likely acceptable) |
| Control 1 | Comparable to Predicate (3.4%) | 1.90% | 3.4% | Yes |
| Control 2 | Comparable to Predicate (2.7%) | 2.29% | 2.7% | Yes |
| Lower Detection Limit | 0.5 IU/mL | 0.5 IU/mL | 0.5 IU/mL | Yes |
| Linearity | 0.5 - 1000 IU/mL (deviation ±10%) | 0.5 - 1000 IU/mL (deviation ±10%) | 0.5 - 1000 IU/mL (deviation ±10%) | Yes |
| Method Comparison correlation (r) | > 0.97 (common for method comparison) | 0.992 | Not applicable (vs. itself) | Yes |
| Method Comparison slope | Close to 1 (e.g., 0.95-1.05) | 0.980 (Least Squares), 1.031 (Passing/Bablok) | Not applicable (vs. itself) | Yes |
| Method Comparison intercept | Close to 0 | 0.639 (Least Squares), -0.208 (Passing/Bablok) | Not applicable (vs. itself) | Yes |
| Hook Effect | No Hook Effect up to 1,000,000 IU/mL AFP | No Hook Effect up to 1,000,000 IU/mL AFP | No Hook Effect up to 1,000,000 IU/mL AFP | Yes |
Notes on Acceptance Criteria:
- For a 510(k) submission demonstrating substantial equivalence, the primary acceptance criterion is that the new device performs as well as or comparably to the predicate device for all relevant performance characteristics.
- The document does not specify explicit numerical acceptance criteria for precision (e.g., "%CV must be
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(16 days)
ROCHE DIAGNOSTICS GMBH
The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay.
Elecsys CalCheck Ferritin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Ferritin concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys CalCheck Ferritin is intended for use in periodic verification of the calibration of the Elecsys Ferritin assay.
The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is manufactured using human serum albumin, Ferritin, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS.
The provided text describes the Elecsys® CalCheck™ Ferritin, a calibration verification material. However, it does not contain a detailed study with acceptance criteria and reported device performance in the manner requested (e.g., accuracy, sensitivity, specificity, or a comparative effectiveness study with human readers).
The document is a 510(k) summary for a calibration verification material. The "Performance Characteristics" section [1] states that the device was evaluated for "value assignment and stability," but no specific metrics, acceptance criteria, or study results are provided in the available text.
Therefore, many of the requested details about acceptance criteria and study design cannot be extracted from this document.
Here's an attempt to answer based on the available information, with specific notes where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states, "The Elecsys® CalCheck™ Ferritin was evaluated for value assignment and stability," but no specific criteria or results are given. | Not provided in the document. No specific quantitative performance metrics (e.g., accuracy, precision, bias, stability over time, or comparison to a reference method) are detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document describes the manufacturing and quality control of the calcheck material [0] but does not mention the origin or type of data used for performance evaluation beyond general "value assignment and stability."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not specified. This device is a calibration verification material. Its "ground truth" would likely be derived from a validated reference method or primary standard for ferritin concentration rather than expert consensus on diagnostic images or clinical cases. The text mentions "quality controlled against ID-GC/MS" during manufacturing [0], which suggests an analytical reference method for concentration assignment, but details are not provided for the test set.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. The concept of adjudication (e.g., 2+1, 3+1 for clinical diagnoses) is not relevant for a calibration verification material whose performance is assessed through analytical measurements against established values.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is typically done for diagnostic or screening devices that involve human interpretation of results (e.g., medical images). The Elecsys® CalCheck™ Ferritin is a calibration verification solution for an automated immunoassay, meaning it does not directly involve human "readers" interpreting test results in a diagnostic context.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study Done: Yes, in an analogous sense. The "value assignment and stability" evaluation of the CalCheck™ Ferritin itself would represent a standalone assessment of its analytical performance (e.g., is the assigned concentration accurate, and does it remain stable over time?). However, the specifics of this study (methods, results, acceptance criteria) are not detailed in the provided text. The device itself is "algorithm only" in the sense that its performance is purely analytical, not based on human input for interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: Analytical reference methods for ferritin concentration. The text mentions the material is "quality controlled against ID-GC/MS" [0], which is a highly accurate analytical technique (Isotope Dilution Gas Chromatography/Mass Spectrometry) often used as a reference method for determining the concentration of substances in a matrix. This suggests that the "ground truth" for the assigned ferritin values in the CalCheck material would be established through such highly accurate analytical techniques.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a calibration verification material, not an AI/ML algorithm that is "trained" on data. It is a physical product with assigned values. Its manufacturing and quality control processes are established, but there isn't a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set." The "ground truth" for the CalCheck's assigned values is established through rigorous analytical measurement processes, likely against primary reference standards using methods like ID-GC/MS, as suggested in the document [0].
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(15 days)
ROCHE DIAGNOSTICS GMBH
The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CA 125II assay.
Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® CalCheck™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay.
The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheck CA 125II is manufactured using human serum albumin, CA 125, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS.
The provided text is for a 510(k) summary for a calibration verification material (Elecsys® CalCheck™ CA 125II), not a medical device in the typical sense of diagnosing or treating a disease. Therefore, many of the requested categories related to clinical performance studies (e.g., expert ground truth, MRMC studies, standalone performance) are not applicable or would not be performed for such a product.
However, I can extract information related to its "performance characteristics" as described for this type of product.
Here's the breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a calibration verification material, "performance" typically refers to its value assignment and stability to ensure it can accurately verify the calibration of an assay. The document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Value Assignment | Evaluated (Implied satisfactory for clearance) |
| Stability | Evaluated (Implied satisfactory for clearance) |
Note: The document states these were "evaluated" but does not provide specific numerical criteria or results. For a calibration verification material, the acceptance criteria would typically involve demonstrating that the assigned values are accurate and that the material remains stable over its declared shelf life when stored properly.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical images or patient data. For a calibration verification material, testing involves manufacturing lots and stability studies.
- Sample Size for Test Set: Not specified in the provided text, but it would pertain to the number of lots or units of the Elecsys® CalCheck™ CA 125II manufactured and tested.
- Data Provenance: Not explicitly stated, but assumed to be from internal lab studies conducted by Roche Diagnostics/Boehringer Mannheim Corporation. This would be prospective manufacturing and stability testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable for a calibration verification material. "Ground truth" for this product type is established through analytical methods for assigning analyte concentrations and stability assessments, not expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable for a calibration verification material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this type of study is not applicable for a calibration verification material. MRMC studies are used for diagnostic devices involving human interpretation of clinical data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a consumable for laboratory assay calibration.
7. The Type of Ground Truth Used
For this device (calibration verification material):
- Ground Truth: Established by analytical methods for determining the concentration of CA 125II in the material (e.g., against reference methods or highly accurate internal standards) and stability studies to confirm the integrity of these concentrations over time. The document mentions it is "in process checked and quality controlled against ID-GC/MS," which implies a rigorous analytical method for quantification, likely for components or precursors, and overall quality control.
8. The Sample Size for the Training Set
Not applicable in the context of machine learning or AI models. The "training set" for this product would be the historical data and expertise used in developing the formulation and manufacturing process of the calibration verification material, and the initial validation batches.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the context of machine learning. The "ground truth" for developing this product would stem from:
- Analytical chemistry principles: To formulate a stable matrix and spike it with known concentrations of CA 125.
- Method validation expertise: To design studies for value assignment and stability testing.
- Manufacturing and Quality Control standards: To ensure consistency across production lots.
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