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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.

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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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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.

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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.

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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.

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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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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:

1. 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.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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, as this is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic imaging device for human readers.
6. 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.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. 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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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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