Search Results
Found 3 results
510(k) Data Aggregation
(271 days)
The Access Total (BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. The assay is intended for use as an aid in the early detection of pregnancy.
The Access Total BhCG (5th IS) calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
The Access Total βhCG (5" IS) assay (standardized to WHO 5" International Standard), Access Total BhCG (5th IS) calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of total βhCG in human serum and plasma.
The provided text describes the performance of the Beckman Coulter Access Total βhCG (5th IS) Assay and Calibrators. The primary "acceptance criteria" for this device, as presented in the 510(k) summary, are derived from various analytical performance studies, which aim to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a separate compiled list. Instead, performance characteristics are presented as results from various studies. I will infer the acceptance criteria from the reported results and the context of device validation for regulatory submission (e.g., meeting established thresholds for imprecision, linearity, etc.).
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Method Comparison (vs. Predicate): | |
| Slope of Passing-Bablok regression: Approximately 1.00 (CI around 1.00) | Slope = 1.04 (95% CI: 1.02 to 1.06) |
| Intercept of Passing-Bablok regression: Approximately 0 mIU/mL | Intercept = 2.87 mIU/mL |
| Pearson correlation (r): Close to 1.00 | r = 0.99 |
| Imprecision (CV% or SD): | |
| Total imprecision for concentrations > 3.9 mIU/mL: |
Ask a specific question about this device
(64 days)
The Access Total βhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total βhCG assay is indicated for use with patients where an early detection of pregnancy status is desired.
The Access Total BhCG assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffer.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that "proves" the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in a quantitative or qualitative manner. Instead, the entire submission hinges on demonstrating "substantial equivalence" to a previously cleared device. Therefore, the "reported device performance" is framed in terms of this equivalence, rather than meeting predefined performance metrics.
However, based on the study performed, we can infer the implicit acceptance criterion was "good correlation" between plasma and serum samples.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| "Good correlation" between plasma and serum samples | "Study results demonstrate good correlation between the plasma and serum samples." |
| Substantial equivalence to predicate device (K980173) | "The Access Total BhCG assay is substantially equivalent to the previously cleared Access Total BhCG assay (K980173)." |
| Same methodology, product type, and quantitative results as predicate device | "Both assays utilize the same methodology, are the same product type, and are quantitative." |
| Including same components as predicate device | "The subject and predicate assays include the same components." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The text states, "a method correlation study, using paired plasma and serum samples, was conducted." However, the exact number of paired samples is not provided.
- Data Provenance: The text does not specify the country of origin. The study was a "method correlation study," which implies it was conducted specifically to support this submission. It is prospective in the sense that the data was generated for the purpose of demonstrating equivalence, and likely involved fresh samples run on the new and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth in this submission. This type of device (quantitative immunoassay for hCG) typically relies on direct measurement and comparison with a reference method or predicate device, rather than expert interpretation of results. The "ground truth" here is the value obtained by the predicate device and the correlation between different sample types.
4. Adjudication Method for the Test Set
No adjudication method is described or implied. As mentioned above, the "ground truth" is based on direct measurement and comparison, not on expert consensus that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. This type of study is typically relevant for interpretative devices where human readers (e.g., radiologists) are involved in assessing images or other complex data, often with and without AI assistance. This submission describes a quantitative in-vitro diagnostic (IVD) assay where the device provides a numerical result, not an interpretation requiring human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is an IVD assay, not an algorithm in the typical sense of AI/ML. The "device performance" described for the Access Total BhCG assay is inherently what would be considered "standalone" clinical performance. It measures hCG levels directly. There is no human "in-the-loop" for the interpretation of the raw quantitative output of the assay, though a clinician would interpret the hCG level in the context of a patient's overall health.
7. The Type of Ground Truth Used
The ground truth used for this study is essentially analytical performance against a legally marketed predicate device (Access Total BhCG assay, K980173) and consistency across different sample matrices (serum vs. plasma). The "truth" for the new device is its ability to produce results that correlate well with the established method and to demonstrate similar performance characteristics.
8. The Sample Size for the Training Set
No training set is described. This context is for a traditional IVD assay, not an AI/ML-based device that would typically involve a distinct training (and validation/test) set. The "supporting data" section focuses on the test set (paired plasma and serum samples) for demonstrating equivalence.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for this specific device, this question is not applicable.
Ask a specific question about this device
(57 days)
The ACCESS® Total βhCG assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of total βhCG in human serum, using the the ACCESS® Immunoassay System.
The Access® Total BhCG reagents and the Access® Immunoassay Analyzer comprise the Access® Immunoassay System for the quantitative determination of total βhCG levels in human serum.
The document describes the acceptance criteria and supporting studies for the Access® Total βhCG assay.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Metric (Criteria) | Reported Device Performance |
|---|---|---|
| Precision | Within-run precision: Not explicitly stated as a criterion, but demonstrated. | Ranges from 1.34% CV |
| Total imprecision: Not explicitly stated as a criterion, but demonstrated. | Ranges from 2.41% CV to 3.38% CV | |
| Accuracy | Dilution recovery: Mean recoveries for two human serum samples. | 97% and 98% (for dilutions from 1:1.2 to 1:32) |
| Correlation | Comparison with predicate device (ACS:180 Total hCG +B assay): Slope and correlation coefficient (r) for 119 human serum samples. | Slope = 0.914, r = 0.98 |
| Analytical Sensitivity | Lowest detectable level of βhCG distinguishable from zero. | 0.5 mIU/ml |
| Analytical Specificity | Cross-reactivity with hLH, hFSH, or hTSH. | No significant cross-reactivity observed. |
| Molar percent specificity of free βhCG subunit (WHO 75/551). | Approximately 200% | |
| Hook Effect | Absence of hook effect at high concentrations. | No discernible hook effect at 1,000,000 mlU/ml. (Predicate assay: patient samples as high as 400,000 mlU/ml will assay > 1000 mlU/ml). |
| Assay Range | Measurement range. | 0.5 mIU/ml - 1000 mIU/ml |
2. Sample size used for the test set and the data provenance:
- Correlation Study (comparison with predicate): 119 human serum samples.
- Accuracy (Dilution Recovery): 2 human serum samples were diluted.
- Precision: Not explicitly stated how many samples were used, but multiple runs/measurements would be implied by CV calculation.
- Analytical Sensitivity: Data supports the lowest detectable level using Access® Total βhCG Calibrator S0.
- Analytical Specificity: Not specified.
- Data Provenance: The data used for these studies are described as "human serum samples." The document does not specify the country of origin of the data, nor does it explicitly state whether the study was retrospective or prospective. Given the nature of these types of lab validation studies, they are typically prospective evaluations of samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in-vitro diagnostic (IVD) assay used for the quantitative determination of βhCG. The "ground truth" for this type of device is established by the known concentration of βhCG in control materials or by comparison with a well-established and standardized reference method. The document does not mention human expert adjudication for establishing ground truth in the context of image interpretation or subjective assessments. Instead, it refers to:
- Standardization: "Both assays are standardized to the WHO 3rd IS 75/537 standard." This international standard serves as the "ground truth" for hCG concentration.
- Predicate Device Comparison: The ACS:180 Total hCG +B assay acts as a comparative reference, implying its results are considered a form of "ground truth" for comparison purposes.
Therefore, no human experts (e.g., radiologists) were used in the way one might for diagnostic imaging studies, as the ground truth is based on biochemical standards and established comparative assays.
4. Adjudication method for the test set:
Not applicable in the context of this IVD device. "Adjudication" usually refers to resolving discrepancies between multiple human readers or a human reader and an AI. For this quantitative immunoassay, the "ground truth" is determined by reference standards and established analytical methods, not human opinion or consensus.
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 an in-vitro diagnostic assay, not an AI-assisted diagnostic imaging or human-in-the-loop system. Therefore, MRMC studies and "improvement with AI vs without AI assistance" are not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies describe the performance of the Access® Total βhCG assay as a standalone system (algorithm/reagent-only) when run on the Access® Immunoassay Analyzer. The results reported for precision, accuracy, analytical sensitivity, and specificity represent the performance of the device without human interpretation or intervention beyond the standard operation of the instrument.
7. The type of ground truth used:
The ground truth for this device's performance studies relies on:
- Reference Standards: The WHO 3rd IS 75/537 standard for hCG concentration.
- Known Concentrations: In spiked samples or controls for dilution recovery.
- Comparative Reference Method: The ACS:180 Total hCG +B assay is used as a comparative "ground truth" for correlation studies.
- Analytical Definitions: For sensitivity (lowest detectable level) and specificity (cross-reactivity with other hormones).
8. The sample size for the training set:
The document does not describe a "training set" in the context of machine learning. This is an immunoassay, not a machine learning algorithm that requires a separate training set. The assay's performance characteristics (e.g., calibration curves, sensitivity parameters) are established through a validation process, but this is distinct from training a machine learning model.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the machine learning sense for this immunoassay. The standardization of the assay's calibration curve and parameters would be established by running known concentrations of calibrators (e.g., Access® Total βhCG Calibrator S0).
Ask a specific question about this device
Page 1 of 1