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510(k) Data Aggregation
(75 days)
The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination r fre lDE Suttonnines adrenaline (epinephrine), noradrenaline (norepinephrine) and/or dopamine (either separate or combined) in human plasma and urine. The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of r he Galecholanine tool hits are asserally of the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma.
Not Found
I am sorry but this document does not contain the requested information. The document is a 510(k) premarket notification letter from the FDA regarding several RIA test kits for catecholamines. While it mentions the device names, regulation numbers, and intended use, it does not provide details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the scientific study reports or summary of safety and effectiveness, which are not included here.
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(127 days)
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.
Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
The IBL Estradiol LIA is a luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol in saliva and serum.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated as distinct pass/fail thresholds in the provided document. Instead, the document presents performance characteristics and comparisons to established methods. The "acceptance" is implied by the FDA's substantial equivalence determination. We can infer the functional performance criteria from the reported values and comparisons.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Normal Ranges in Saliva | Establish distinct ranges for different physiological states. | Premenopausal (n=28): Follicular phase 0.6 - 10.4 pg/mL; Mid-cycle Peak 4.5 - 21.2 pg/mL; Luteal phase 0.5 - 10.8 pg/mL.Postmenopausal (n=5): < 3.2 pg/mL. Males (n=40): < 3.4 pg/mL. |
| Comparison to Published Saliva RIA | High correlation and close agreement with established methods. | r² = 0.97 with a regression formula of Y = 0.96 * RIA + 0.55 (n=50 saliva samples). Range measured: 0-51 pg/mL (RIA), 0-55 pg/mL (LIA). |
| Comparison to Commercial Serum RIA | High correlation and close agreement with established methods. | r² = 0.95 with a regression formula of Y = 1.00 * RIA - 4.83 (n=60 serum samples). Range measured: 22 - 448 pg/mL (RIA), 2 - 444 pg/mL (LIA). |
| Serum to Saliva Comparison | Demonstrate a relationship between serum and saliva levels. | R² = 0.712 with a regression formula of serum (pg/mL) = 43.491 * (saliva) - 4.680. |
| Cross-Reactivity | Minimal cross-reactivity with structurally similar or common interfering substances. | 17β-Estradiol: 100.0%Estrone: 0.222%Estriol: 0.138%Other substances (Corticosterone, Dexamethasone, Cortisone, Progesterone, Testosterone, Prednisolone): ≤ 0.01% |
| Analytical Sensitivity (LoD) | Low limit of detection for accurate measurement of low concentrations. | Saliva: 0.3 pg/mL (Mean signal (Zero-Standard) - 2SD)Serum: 7.3 pg/mL (Mean signal (Zero-Standard) - 2SD) |
| Functional Sensitivity | Concentration at which CV is <20%. | Saliva: 0.78 pg/mL (Mean Conc. <20% CV)Serum: 8.0 pg/mL (Mean Conc. <20% CV) |
| Precision (Intra-Assay & Inter-Assay) | Low coefficient of variation (CV) at different concentrations. | Saliva Intra-Assay: CVs from 3.7% to 7.9% (n=10)Saliva Inter-Assay: CVs from 5.9% to 13.9% (n=10)Serum Intra-Assay: CVs from 3.1% to 7.4% (n=10)Serum Inter-Assay: CVs from 4.3% to 9.3% (n=10) |
| Linearity | Measured values should be proportional to expected concentrations across a range of dilutions. | Saliva: Recoveries from 80% to 114% for various dilutions.Serum: Recoveries from 83% to 117% for various dilutions. |
| Recovery | Measured values should be close to added values. | Saliva: Recoveries from 92% to 128% for various spiked concentrations in 3 different saliva samples.Serum: Recoveries from 80% to 96% for various spiked concentrations in 3 different serum samples. |
2. Sample Sizes Used for the Test Set and Data Provenance
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Normal Ranges in Saliva:
- Premenopausal Women: 28 women (month profiles, so multiple samples per woman), age 19-43.
- Postmenopausal Women: 5 women, age 42-62.
- Males: 40 males, age 20-63.
- Data Provenance: Not explicitly stated, but likely prospective for the normal range establishment as saliva samples were collected daily "until first day of bleeding" or as single samples for postmenopausal women and males. No country of origin is specified, but the manufacturer is based in Germany, suggesting European or international data.
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Comparison of Serum and Saliva (to published/commercial RIA):
- Saliva Comparison: 50 saliva samples.
- Serum Comparison: 60 serum samples.
- Data Provenance: Not explicitly stated, but likely retrospective or a combination of prospective/retrospective for convenience from adult healthy individuals. No country of origin is specified.
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Serum to Saliva Comparison (using IBL Estradiol LIA):
- Paired Samples: Not explicitly stated, but derived from "saliva and serum pairs collected at the same time." The number of pairs is not provided.
- Data Provenance: Not explicitly stated, but likely prospective for this specific comparison.
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Cross-Reactivity, Analytical Sensitivity, Functional Sensitivity, Precision, Linearity, Recovery:
- The sample sizes for these analytical performance studies are embedded within the tables (e.g., n=10 for precision at each level). These are typically laboratory studies using spiked samples, controls, and calibration materials rather than patient samples for the direct "test set" definition often associated with diagnostic device clinical trials.
- Data Provenance: Laboratory validation studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Normal Ranges: The "ground truth" here is the observed ranges in the healthy populations studied. There is no mention of external experts establishing a ground truth for these ranges; they are empirical observations from the study participants themselves.
- Comparison Studies: The "ground truth" for the comparison studies are the results obtained from the "published procedure that used a modification in the handling of saliva for a typical RIA test" and a "commercially available RIA test kit." These are established reference methods. There is no mention of individual expert adjudicators for these data points.
4. Adjudication Method for the Test Set
Not applicable in the context of this device. The comparisons are against established laboratory methods, not subjective diagnoses requiring adjudication by human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic immunoassay, not an imaging or diagnostic device requiring interpretation by human readers. Therefore, an MRMC study and effects of AI assistance are not relevant to this submission.
6. Standalone Performance Study
Yes, the entire submission describes the standalone performance of the IBL Estradiol LIA. The comparisons to RIA methods ("Comparison of Serum and Saliva," "Serum to Saliva Comparison") are designed to demonstrate its performance relative to existing technologies, but the listed metrics (Normal Ranges, Cross-reactivity, Sensitivity, Precision, Linearity, Recovery) represent the intrinsic performance of the IBL Estradiol LIA device itself.
7. Type of Ground Truth Used
- Normal Ranges: Empirical observation from defined healthy populations.
- Comparison Studies: Results from established, commercially available, or published reference immunoassay methods (RIA).
- Analytical Performance (Cross-Reactivity, Sensitivity, Precision, Linearity, Recovery): These are based on established laboratory analytical methods using controlled samples, calibrators, and known concentrations (e.g., spiked samples).
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI development. For an immunoassay, the equivalent would be the samples used to develop and optimize the assay's reagents, protocols, and calibration curves. This information is not provided in detail. The normal range studies and comparison studies would be considered part of the validation and testing, rather than a "training set" in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
As there is no distinct "training set" discussed in the context of AI/ML, this question is not directly applicable. However, for the development of the immunoassay itself, the "ground truth" for calibrators and controls would be established through rigorous analytical chemistry techniques, often traceable to international standards, and verified by expert analytical chemists during the assay development phase. The document implicitly relies on standard immunoassay development and validation practices.
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(105 days)
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva. Measurements obtained by this device may be used in the diagnosis and treatment of disorders of the ovaries and can be used as an aid for confirmation of ovulation.
Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
IBL Progesterone LIA - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the performance characteristics of the IBL Progesterone LIA. The acceptance criteria for these characteristics are not explicitly stated as distinct thresholds in the document, but rather the reported performance values themselves serve as the demonstration of the device's capability. For this analysis, we will interpret the reported performance as meeting the implicit acceptance criteria for a device of this type.
| Performance Metric | Reported Device Performance |
|---|---|
| Analytical Specificity (Cross-Reactivity) | |
| 17α-Hydroxyprogesteron | 1.84% |
| 6α-Methyl-17α-Hydroxyprogesteron | 1.41% |
| Pregnenolone | 0.41% |
| Deoxycorticosterone | 0.28% |
| Androsterone Sulfat | 0.25% |
| Androstenedion | 0.20% |
| Androsterone | 0.20% |
| DHEA-S | 0.11% |
| Corticosterone | 0.06% |
| Other substances tested | ≤ 0.1 % |
| Analytical Sensitivity (Limit of Detection) | 2.6 pg/mL (Mean signal (Zero-Standard) - 2SD) |
| Precision | |
| Intra-Assay (10 measurements) | Range (pg/mL): 11.5 - 822; CV (%): 6.0 - 0.7 |
| Inter-Assay (10 measurements) | Range (pg/mL): 10.6 - 817.1; CV (%): 18.8 - 3.4 |
| Linearity | Range (pg/mL): 7.5 - 779; Range (%): 78 - 120; Mean (%): 97 (Serial dilution up to 1:32) |
| Recovery | Range (pg/mL): 27 - 1497; Range (%): 82 - 121; Mean (%): 103 |
| Comparison Study | Correlation with a published RIA method: r² = 0.94, Regression formula: Y = 0.89 * RIA + 25.5 pg/mL |
| Normal Ranges (Reference Values) | Premenopausal Females (n=27 month profiles): Follicular phase: 28 - 82 pg/mL, Luteal phase (peak max): 127 - 446 pg/mL Postmenopausal Females (n=6): 18 - 51 pg/mL Males (n=49): < 59 pg/mL |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical cycle profiling: 27 pre-menopausal women, 6 post-menopausal women, and 49 males.
- Comparison study: 97 adult healthy populations.
- Data Provenance: The document does not explicitly state the country of origin for the data. It mentions the manufacturer as IBL Immuno Biological Laboratories in Hamburg, Germany, which suggests the studies were likely conducted or overseen in Germany or Europe. The study is prospective for the clinical cycle profiling (samples collected throughout menstrual cycles), and likely also prospective or from a specific collection for the healthy populations in the comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth.
For the comparison study, the "ground truth" was established by a "published procedure that used a modification in the handling of saliva for a typical RIA test." This implies a reference analytical method was used as the ground truth, rather than expert clinical judgment.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by a reference analytical method, not by human expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The study focused on the analytical performance of the device and its correlation with a reference method, not on the impact of the device on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies reported in the document describe the standalone performance of the IBL Progesterone LIA device. The device autonomously measures progesterone levels in saliva. The comparison study assesses its agreement with a reference analytical method, which is a form of standalone performance evaluation.
7. The Type of Ground Truth Used
- For Analytical Performance (Specificity, Sensitivity, Precision, Linearity, Recovery): The ground truth is inherent in the analytical standards and reference materials used to challenge the assay and measure its performance characteristics. These are established laboratory methods.
- For Comparison Study: The ground truth was a published procedure using a modified RIA test for saliva progesterone. This serves as a reference method.
- For Normal Ranges: The "ground truth" here is the measured progesterone levels in a defined healthy population (pre-menopausal women, post-menopausal women, males) over specific physiological periods (menstrual cycle phases).
8. The Sample Size for the Training Set
The document does not explicitly describe a "training set" in the context of an algorithm or AI. The IBL Progesterone LIA is a luminescence immunoassay, not an AI/machine learning algorithm that requires a separate training phase. All listed sample sizes (27 pre-menopausal women, 6 post-menopausal women, 49 males, and 97 adult healthy populations) are related to the evaluation/test of the device's performance characteristics and establishment of reference ranges, not for training a model.
9. How the Ground Truth for the Training Set was Established
As noted above, there is no explicit "training set" for an AI/machine learning model. The device is a biochemical assay. The "ground truth" for evaluating its performance (as detailed in point 7) was established through scientifically accepted analytical methods and reference procedures.
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(85 days)
The IBL Testosterone Luminescence Immunoassay is intended for the in vitro quantitative measurement of testosterone (a male sex hormone) in saliva and serum. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
Not Found
The provided text is a regulatory clearance letter from the FDA for a medical device, specifically the "IBL Testosterone Luminescence Immunoassay." It primarily focuses on the device's classification and substantial equivalence to existing devices.
Crucially, this document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The letter states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device's performance was compared to a previously cleared device, not necessarily against a set of predefined acceptance criteria in the manner one might expect for a novel or high-risk device requiring detailed clinical trials.
To answer your questions, I would need access to the actual 510(k) premarket notification dossier submitted by IBL-Hamburg, GmbH to the FDA, which would contain the performance data and study details supporting their claim of substantial equivalence.
Therefore, I cannot provide the requested table or information based solely on the text provided.
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(127 days)
The IBL C3d-CIC test is a semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum.
I apologize, but the provided text from the FDA 510(k) clearance letter for the "IBL C3d-CIC EIA Test" does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The letter primarily covers:
- The FDA's determination of substantial equivalence to a predicate device.
- Regulatory classifications and requirements.
- Contact information for various FDA offices.
- The "Indications For Use" statement for the device.
It explicitly states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the FDA's decision is based on a comparison to an existing device, rather than a detailed presentation of a new study demonstrating performance against specific acceptance criteria within this document. Such study details are typically found in the full 510(k) submission, which is not provided here.
Therefore, I cannot extract the following information from the given text:
- A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or performance metrics for the IBL C3d-CIC EIA Test itself.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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, as this is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging device for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is an IVD kit, not an algorithm. Its performance is its standalone performance.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The "Indications For Use" section provides context for the device's purpose:
- Device Name: IBL C3d-CIC EIA Test
- Indications For Use: A semi-quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C3d in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
To get the information you're looking for, one would need access to the full 510(k) submission document (Premarket Notification) itself, which contains the detailed scientific and clinical data submitted to the FDA.
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(38 days)
The IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "IBL C1q-CIC EIA Test". This document outlines the regulatory approval for an in vitro diagnostic device and does not contain the details of a study that describes acceptance criteria for device performance. It establishes that the device is substantially equivalent to legally marketed predicate devices, but doesn't provide specific performance metrics or the study design used to validate the device's accuracy.
Therefore,Based on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: The document is a 510(k) clearance letter and does not include performance data or acceptance criteria.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available in this document.
- If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not available in this document.
- The type of ground truth used: Not available in this document.
- The sample size for the training set: Not available in this document.
- How the ground truth for the training set was established: Not available in this document.
The document states the "IBL C1q-CIC test is a quantitative enzyme immunoassay for the in vitro diagnostic detection of circulating immune complex that bind C1q in human serum. The measurement is performed as an aid in the diagnosis of various autoimmune and other CIC related diseases. Levels of these complexes are one indicator in a multi-factorial diagnostic regime." This is the device's intended use and contribution to diagnosis, but not its performance metrics.
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