(31 days)
The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-1 in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.
The DSL Active IGF-1 ELISA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum. This ELISA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the microtitration wells. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the anti-IGF-I antibody conjugated to the enzyme horseradish peroxidase.
Here's an analysis of the provided text regarding the DSL 10-2800 IGF-I ELISA Kit, focusing on acceptance criteria and study details.
Based only on the provided text, the concept of "acceptance criteria" is implicit rather than explicitly stated with numerical targets for performance metrics like sensitivity or specificity. The primary reported performance metric is the correlation coefficient (r) between the new device and a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Strong correlation with predicate device (DSL 2800 IGF-I IRIMA) | Correlation Coefficient (r) = 0.82 |
| Measurement of IGF-I levels across a range (low, intermediate, high) | Y = 0.60(X) + 0.73 (linear regression equation) |
Explanation of "Acceptance Criteria" in this Context: The document describes a "Summary of Safety and Effectiveness" for a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device. In this regulatory pathway, demonstrating substantial equivalence often involves showing comparable performance, rather than meeting pre-defined, absolute performance thresholds (like 90% sensitivity). The strong correlation (r = 0.82) and the linear regression are presented as the evidence of this comparable performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 319 patient samples.
- Data Provenance: The text states "patient samples...were collected." It does not specify the country of origin. Given the submitter's address is in the USA ("Webster, Texas, USA"), it is most probable the data is from the USA, but this is not explicitly stated. The nature of the study (comparing a new device to an existing one) suggests elements of both retrospective (analyzing existing samples) and prospective (collecting samples specifically for this comparison) could be involved, but the text doesn't specify. However, "samples were collected" often implies prospective collection for the purpose of the study.
- Selection: "Samples were chosen based on expected IGF-I levels so that samples with low, intermediate and high levels of IGF-I would be evaluated." This indicates a targeted selection rather than a purely random sample.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Mentioned. For this type of in vitro diagnostic device comparison study (comparing two assays that measure the same analyte), "ground truth" isn't typically established by human expert consensus on images or observations. Instead, the "truth" for comparison is the result obtained from the predicate device (DSL 2800 IGF-I IRIMA).
4. Adjudication Method for the Test Set
- Not Applicable / Not Mentioned. Adjudication methods (like 2+1, 3+1) are typically used when human readers or clinicians disagree on an interpretation, and a third party resolves the discrepancy. This study compares quantitative measurements from two laboratory assays. Discrepancies would be analyzed statistically, not through human adjudication in the traditional sense.
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
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. This study is not a medical imaging or AI-assisted diagnostic study involving human readers. It's a comparison of two in vitro diagnostic (IVD) assays.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Yes, a standalone study was done. This study evaluates the DSL 10-2800 IGF-I ELISA Kit as a standalone assay, directly comparing its quantitative results to a predicate device. There is no human interpretation component described in the performance evaluation presented.
7. The Type of Ground Truth Used
- Reference Method Comparison / Predicate Device Results. The "ground truth" for this study is essentially the results obtained from the DSL 2800 IGF-I IRIMA, which is the predicate device. The new device's performance is measured by its agreement with this established method.
8. The Sample Size for the Training Set
- Not specified. The document describes a performance evaluation for substantial equivalence, which is typically a validation study using a test set. It does not mention a "training set" for the development of the DSL 10-2800 IGF-I ELISA Kit. ELISA kits are developed through biochemical and immunoassay optimization, not typically through machine learning training sets in the same way an AI algorithm would be.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not mentioned. As there's no training set described in the context of an AI/machine learning model, the concept of "ground truth for the training set" as it relates to expert consensus or pathology is not relevant here. The "training" for an ELISA kit involves optimizing reagents, concentrations, and protocols to achieve desired performance characteristics.
§ 862.1370 Human growth hormone test system.
(a)
Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.(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.