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510(k) Data Aggregation
(153 days)
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
The DSL 10-8400 AFP ELISA assay is intended for the quantitative determination of AFP in human serum. It is intended for in vitro diagnostic use to aid in the management of patients with nonseminomatous testicular cancer.
The DSL-10-8400 ACTIVE™ AFP ELISA is an enzymatically amplified "two-step" sandwichtype immunoassay. In the assay, Standards, Controls and unknown serum samples are incubated in microtitration wells which have been coated with anti-AFP antibody. After incubation and washing, the wells are treated with another anti-AFP detection antibody labelled with the enzyme horseradish peroxidase (HRP). After a second incubation and washing step, the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the degree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement at 450 and 620 nm.
The absorbance measured is directly proportional to the concentration of AFP present. A set of AFP Standards is used to plot a standard curve of absorbance versus AFP concentration from which the AFP concentrations in the unknowns can be calculated.
Here's an analysis of the DSL 10-8400 ACTIVE™ AFP ELISA Kit's acceptance criteria and the studies performed, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a pass/fail format for each performance characteristic. Instead, it presents the results of various performance studies. For the purpose of this response, I infer "acceptance criteria" from the reported performance, implying that the reported values were deemed acceptable for the device's intended use and for demonstrating substantial equivalence to the predicate device.
| Performance Characteristic | Inferred Acceptance Criterion (Based on reported performance) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Linear regression analysis of comparison data to predicate device should show strong correlation (r ≥ 0.99 for this type of assay). | Y = 1.0(X) + 5.8 with a correlation coefficient of (r) = 0.99 (compared to Abbott IMx AFP Immunoassay) |
| Sensitivity (Limit of Detection) | Low detection limit to identify clinically relevant AFP levels. (No explicit threshold given; 0.7 ng/mL is reported as the theoretical minimum). | 0.7 ng/mL |
| Intra-assay Precision (CV) | Acceptable coefficient of variation (CV) for within-run reproducibility. (Generally, CV 8.9 - 100 ng/mL, 6.7% > 100 - 400 ng/mL, 13.3% > 400 ng/mL). |
2. Sample Size Used for the Test Set and the Data Provenance
- Substantial Equivalence Study (Method Comparison):
- Sample Size: 73 male human serum samples.
- Data Provenance: Not explicitly stated, but "human serum samples" implies clinical samples. Whether they were retrospective or prospective is not specified. The country of origin is not specified, but the submitter is based in Webster, Texas, USA.
- Performance Characteristics (Analytical Studies - Precision, Recovery, Linearity, Specificity, Sensitivity): These studies typically use a controlled set of samples (e.g., pooled human serum, spiked samples, diluted samples).
- Sample Size:
- Sensitivity: 22 replicates of 0 ng/mL AFP Standard.
- Intra-assay Precision: 14 replicates for each of 3 male human serum samples.
- Inter-assay Precision: 4 replicates for each of 3 human serum samples, done in 2 separate runs each day for 20 days.
- Recovery: 3 male human serum samples, each spiked with 3 different AFP amounts.
- Linearity: 3 male human serum samples, each diluted at multiple factors.
- Data Provenance: "Male human serum samples" is stated for some. These are laboratory-based analytical studies, not clinical patient data. The origin isn't specified beyond "human serum."
- Sample Size:
- Expected Values (Normal Population):
- Sample Size: 199 healthy adult males, 72 healthy adult females.
- Data Provenance: Not explicitly stated, but "a study conducted with apparently normal healthy adults" implies prospective collection for assay validation. Country of origin not specified.
- Longitudinal Study (Clinical Utility):
- Sample Size: 3 patients with diagnosed nonseminomatous testicular cancer were serially monitored. Additionally, 15 male patients with nonseminomatous testicular cancer had their AFP levels determined.
- Data Provenance: Clinical patient data. Retrospective or prospective is not explicitly stated for the 15 patients; for the 3 longitudinal patients, it implies prospective monitoring or use of stored serial samples. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of "experts" being used to establish ground truth in the context of this device's analytical or clinical performance evaluation.
- For the Substantial Equivalence study: The "ground truth" was based on the measurement by the predicate device (Abbott IMx AFP Immunoassay).
- For analytical performance (Precision, Recovery, Linearity, Sensitivity): The "ground truth" or true value is based on the known concentrations of standards, spiked amounts, or calculated values from dilutions. These are intrinsic to the assay's design and laboratory experimentation.
- For Expected Values and Longitudinal Studies: The "ground truth" for patient diagnosis (nonseminomatous testicular cancer) would have been established by standard clinical diagnostic procedures (e.g., histology, imaging, clinical presentation), which would implicitly involve expert medical practitioners, but the document does not detail this. The AFP values themselves are the direct measurements from the device in these studies.
4. Adjudication Method (for the test set)
No adjudication method is described. For most in vitro diagnostic (IVD) assays, particularly quantitative ones like ELISA, adjudication by experts for ground truth is not typically part of the analytical validation or method comparison. The measured values from the device or the predicate device are directly compared or analyzed. Clinical outcomes (disease diagnosis, response to treatment) form the "ground truth" for clinical utility, which is established through standard medical practice rather than an active adjudication process for the purpose of validating the assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret images with and without AI assistance. The DSL 10-8400 ACTIVE™ AFP ELISA Kit is an in vitro diagnostic assay that provides a quantitative numerical result, and therefore, an MRMC study is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are primarily standalone performance assessments of the DSL 10-8400 ACTIVE™ AFP ELISA Kit. The device provides a quantitative measurement of AFP; it doesn't involve a "human-in-the-loop" for interpretation in the same way an imaging AI might. The clinical utility studies demonstrate how the results from the device aid in patient management, but the performance characteristics (sensitivity, precision, recovery, etc.) are evaluating the device itself, separate from human interpretation or modification of its direct output.
7. The Type of Ground Truth Used
- Substantial Equivalence Study: The predicate device's (Abbott IMx AFP Immunoassay) results served as the reference or "ground truth" for comparison.
- Analytical Performance Studies (Sensitivity, Precision, Recovery, Linearity, Specificity): The "ground truth" was based on known concentrations of standards, known amounts of spiked AFP, or expected values from dilutions.
- Expected Values Study: The "ground truth" for these samples was based on the clinical status of the individuals (apparently normal healthy adults).
- Longitudinal / Clinical Utility Studies: The "ground truth" for these patients was established through clinical diagnosis of nonseminomatous testicular cancer and monitoring of their clinical course and response to treatment, presumably via established medical diagnostic and monitoring protocols (e.g., biopsy/histology, imaging, other markers).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This is an ELISA kit, which is a biochemical assay. The "training" of such a device would involve optimizing the assay reagents and protocols during development. The various performance studies mentioned serve as validation of the developed assay.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/machine learning device, the concept of a "training set" and its "ground truth" in the AI sense does not apply. The development of the assay (akin to "training" in a broader sense) would involve extensive experimentation with known AFP concentrations in various matrices to establish optimal antibody concentrations, incubation times, substrate reactions, and standard curve parameters. The "ground truth" for such development would be the precisely known concentrations of AFP standards and controls.
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