Search Results

Ask a specific question about this device

Bioclot® aPC Sensitivity is intended for the determination of resistance to activated protein C in human plasma using a clotting assay.

Activated Protein C Resistance (aPC) is a hereditary defect which appears to play an important role in thrombophilia.

Not Found

I apologize, but the provided text from the FDA 510(k) approval letter for the Bioclot® aPC Sensitivity Kit does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

The document is a letter indicating substantial equivalence to a predicate device, allowing the kit to be marketed. It does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes for test or training sets, data provenance, or ground truth establishment.
• Information on expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
• Results from standalone algorithm performance studies.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device

The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombine Time (PT), and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges.

The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly.

Not Found

This document is a 510(k) clearance letter from the FDA for the i-STAT Coagulation Control Set. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a new diagnostic or AI-powered device.

This clearance is based on substantial equivalence to a predicate device, meaning the new device is as safe and effective as another legally marketed device. The letter primarily confirms that the device can be marketed based on this determination.

Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies are not applicable to the information provided in this regulatory document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the intended use of the controls as "to provide a method for verifying the integrity of newly received cartridges" and states that "The controls produce clotting times within normal ranges and abnormal ranges to indicate that the test cartridges are functioning properly."

While a formal table of acceptance criteria with specific threshold values (e.g., +/- 10% of expected value) is not provided in this FDA letter, the implied acceptance criteria are that the i-STAT Coagulation Control Set, when used with i-STAT aPTT, PT, and ACT test cartridges, produces:

2. Sample size used for the test set and the data provenance: Not applicable to this type of regulatory submission. The FDA relies on the manufacturer's data demonstrating substantial equivalence, which would include internal testing, but the details of such testing (like sample size for a "test set" in the context of an AI/diagnostic algorithm) are not explicitly in this letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to coagulation control solutions, not an AI or diagnostic algorithm requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No. This is not relevant for a coagulation control set.

6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a control solution for an analyzer, not a standalone algorithm.

7. The type of ground truth used: For a control solution, the "ground truth" would be the known, expected values or ranges of the clotting parameters being measured, established through analytical methods and possibly reference laboratories. This is not explicitly stated but is the inherent nature of a control.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Fetal D Tection Kit is indicated for use to test blood samples drawn from D negative mothers who have delivered D positive infants. The blood sample should be drawn shortly after all products of conception have been delivered, and then assayed as soon as possible, since RhIg should be administered to the mother within 72 hours of delivery to be effective. Positive result in this qualitative test indicates the need to perform a quantitative test to determine if more than one 300 mg dose of RhIg will adequately protect the mother from being sensitized to the D antigen.

Not Found

This looks like a 510(k) clearance letter for the "Fetal D Tection Kit" and does not contain the detailed study information you are requesting. A 510(k) letter primarily indicates that the FDA has found the device to be "substantially equivalent" to a legally marketed predicate device.

The information you are asking for, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, and study designs, would typically be found in the manufacturer's 510(k) submission document itself, or in associated study reports. These details are generally not included in the FDA's clearance letter.

Therefore, I cannot fulfill your request using only the provided text.

Ask a specific question about this device