(41 days)
The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Not Found
This FDA 510(k) clearance letter dated November 24, 1997, for the KMI Diagnostics, Inc. 17 ß-Estradiol (ELISA) test kit, does not contain the detailed information necessary to complete a comprehensive table of acceptance criteria, device performance, and study characteristics.
The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, allowing the manufacturer to market the device. It states the "Indications for Use" but does not provide specific performance metrics, study designs, or ground truth methodologies.
Therefore, I cannot fully address the request with the information provided.
However, I can extract the following limited information:
Indications for Use (from the document):
"The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy."
Based on the typical regulatory requirements for ELISA kits at the time, and the "substantial equivalence" claim, the acceptance criteria would generally refer to demonstrating comparable performance to an existing, legally marketed device (the predicate device). This would involve analytical performance studies rather than clinical efficacy studies on patient outcomes.
Here is what a hypothetical response might look like if the requested information were present in the document, along with an explanation of why I cannot fill it based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Hypothetical) | Acceptance Criteria (Hypothetical) | Reported Device Performance (Not Available in Document) |
|---|---|---|
| Analytical Sensitivity (Detection Limit) | Should be ≤ X pg/mL | [Information not provided in the document] |
| Analytical Specificity (Cross-reactivity) | Cross-reactivity to interfering substances ≤ Y% | [Information not provided in the document] |
| Precision (Intra-assay CV) | CV ≤ Z% | [Information not provided in the document] |
| Precision (Inter-assay CV) | CV ≤ A% | [Information not provided in the document] |
| Accuracy (Correlation with reference method) | R² ≥ 0.95 with established reference method | [Information not provided in the document] |
| Linearity of Dilution | % Recovery within B% of expected value | [Information not provided in the document] |
| Measuring Range | X to Y pg/mL | [Information not provided in the document] |
Explanation: The provided 510(k) summary letter does not include specific analytical performance metrics or the acceptance criteria for these metrics. The letter confirms "substantial equivalence" but does not detail the data supporting this claim.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not available in the document.
- Data Provenance: Not available in the document (e.g., country of origin, retrospective/prospective).
Explanation: The document does not describe the specific study data used to demonstrate equivalence, including the number of samples or their origin. For ELISA kits, this would typically involve analytical samples (spiked samples, patient samples compared to a reference method).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not available in the document.
- Qualifications of Experts: Not applicable/Not available in the document.
Explanation: For an in vitro diagnostic (IVD) device like an ELISA kit, ground truth is typically established through a reference method (e.g., GC-MS, LC-MS/MS, or a well-established, previously cleared ELISA). It usually does not involve expert readers or adjudication in the same way an imaging or pathology device might.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not available in the document.
Explanation: As mentioned above, this type of device's "ground truth" is analytical, not based on expert review requiring adjudication.
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
- MRMC Study Done?: No.
- Effect Size: Not applicable.
Explanation: This is an immunoassay (ELISA) kit, not an AI-powered diagnostic imaging or pathology device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Done?: Yes, the device itself is a standalone laboratory test.
Explanation: The ELISA kit is a laboratory test run by trained technicians. Its performance is measured directly, without a human-in-the-loop interaction in the diagnostic interpretation once the assay is complete.
7. The type of ground truth used
- Type of Ground Truth: Not specified in the document.
Explanation: Typically for an ELISA, the ground truth would be established by comparing results from the investigational device to a recognized "gold standard" or reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS/MS), or a well-validated predicate immunoassay). The document does not specify which was used.
8. The sample size for the training set
- Sample Size for Training Set: Not relevant or available in the document.
Explanation: ELISA kits are developed using biochemical principles and reagents, not machine learning algorithms that require "training sets" in the AI sense. While method development involves optimization, it's not analogous to an AI training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set Established: Not relevant or available in the document.
Explanation: As above, this concept of a "training set" and its "ground truth" is not directly applicable to the development and validation of an ELISA assay in the context of this 1997 regulatory submission.
§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(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.