Search Results

The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.

The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic.

The Safety-Needle is intended to be used in all hospitals and/or practices where S-Monovettes are used.

The Safety-Needle is a single lumen needle for blood collection via venipuncture in conjunction with the S-Monovette® system. The Safety-Needle needle protector, when activated after removal of the needle from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.

The Safety-Needle is individually packaged, sterile, single-use and non-pyrogenic.

I am sorry, but the provided text is a 510(k) summary for a medical device (Safety Needle) and does not contain information about acceptance criteria, study details, or performance data. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It confirms marketing authorization but does not include any studies or data proving the device meets specific acceptance criteria in the way you've described.

Therefore, I cannot fulfill your request for the table of acceptance criteria and study data based on the provided text.

Ask a specific question about this device

The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components.

The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.

Not Found

This document is a 510(k) premarket notification for a medical device, specifically a "S-Monovette EDTA K2-Gel" blood collection tube. It outlines the FDA's decision regarding substantial equivalence to a predicate device and provides information on the intended use of the device.

However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations of AI/ML-driven or diagnostic/screening devices for which the requested information (e.g., sample size for test set, number of experts, adjudication method, AI vs. human performance) would be relevant.

This document pertains to a blood specimen collection device, which is a Class II medical device. The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness through comparisons of design, materials, performance, labeling, and intended use. Performance testing for a blood collection device would typically involve demonstrating its ability to properly collect, store, and process blood specimens according to its stated indications, and to ensure the blood components (e.g., plasma) are suitable for subsequent laboratory testing. This would involve chemical stability, sterility, and physical integrity studies rather than diagnostic accuracy studies with ground truth.

Therefore, I cannot extract the requested information (Table of acceptance criteria, sample size, expert qualifications, etc.) because it is not present in this type of FDA 510(k) summary for a blood collection device. The information requested is more relevant for diagnostic devices that analyze patient data to make a clinical determination.

Ask a specific question about this device

The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector. The Safety-Multifly® is intended for blood collection via venipuncture. The Safety-Multifly® needle protector, when activated after removal from the patient, covers the used needle until it can be properly disposed; therefore, aiding in the prevention of needle stick injuries.

The Safety-Multifly® is individually packaged. sterile, single-use and non-pyrogenic.

The Safety-Multifly® is intended to be used in all hospitals and/or practices where S-Monovettes are used.

The Safety-Multifly® is a winged blood collection needle set with flexible tubing, an adapter for the S-Monovette® system, and an integral needle protector.

This document is a 510(k) premarket notification acceptance letter for a medical device (Safety-Multifly®), not a study report. Therefore, it does not contain the detailed clinical trial or performance study information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Type of Document: This is a regulatory approval letter from the FDA, confirming that the Safety-Multifly® device is "substantially equivalent" to legally marketed predicate devices. It is not a clinical study report or a detailed technical performance report.
• Focus of 510(k): The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness. It often relies on comparisons to existing devices and bench testing rather than extensive new clinical trials, especially for Class II devices like this one.

Because the document only states that the device is "substantially equivalent" to predicate devices, it does not provide the specific data requested in your prompt. The FDA's determination of substantial equivalence implies that the device meets the safety and effectiveness standards comparable to the predicate device, but the details of how that was demonstrated (e.g., through specific acceptance criteria and a study) are not included in this letter.

Ask a specific question about this device

The Urine Monovette® boric acid is intended for use as a urine collection and transport device that maintains the integrity of the urine for delayed microbiological urine analysis

Urine Monovette® boric acid

The provided document is a 510(k) premarket notification letter from the FDA for the "Urine Monovette® boric acid" device. This document confirms the substantial equivalence of the device to a predicate device and allows it to be marketed.

However, the letter does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment for the device's efficacy or performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

Therefore, I cannot provide the requested information based on the content of this document. This letter is an approval for marketing based on substantial equivalence, not a detailed report of performance testing or clinical studies.

Ask a specific question about this device

Ask a specific question about this device