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The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of various therapeutic treatments of prostate cancer patients. (for Professional use only)

The UBI MAGIWELTM prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA).

This document is a marketing authorization letter for the UBI MAGIWEL™ PAP EIA Quantitative device (K981573) from the FDA dated September 15, 1998. It states that the device is substantially equivalent to legally marketed predicate devices. The document also includes an "Indications for Use" statement. However, it does not contain any information regarding acceptance criteria, study details, or performance data of the device.

Therefore, I cannot provide the requested information based on the provided text. The document is solely an authorization letter and does not include the technical details of the device's performance or the studies conducted to support its claims.

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The UBI MAGIWEL™ Marijuana metabolites is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Marijuana metabolites in human urine. (for Professional use only)

solid phase enzyme-linked immunosorbent assay(ELISA)

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

Instead, the letter primarily focuses on the FDA's determination of substantial equivalence for the "UBI MAGIWEL Marijuana Metabolites" device, its regulatory class, and the general controls and regulations it is subject to. It also outlines responsibilities of the manufacturer regarding CLIA categorization, labeling, promotion, and advertising.

Therefore, I cannot extract the requested information from the provided input.

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The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of CRP level in human serum to aid in the evaluation of the amount of injury to body tissues. (for Professional use only)

The UBI MAGIWEL™ C-Reactive Protein(CRP) AD-401 is a solid phase enzyme-linked immunosorbent assay(ELISA).

This is a letter from the FDA regarding the 510(k) premarket notification for the UBI MAGIWEL™ C-Reactive Protein (CRP) Quantitative AD-401 device. The document states that the device is substantially equivalent to legally marketed predicate devices and can proceed to the market.

However, the provided text does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, data provenance, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or the specific type of ground truth used.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.

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The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides qualitative measurement of Opiate metabolites in human urine. (for Professional use only)

The UBI MAGIWEL™ Opiate metabolites is a solid phase enzymelinked immunosorbent assay(ELISA).

This document is a 510(k) clearance letter from the FDA for a medical device (UBI MAGIWEL™ Opiates Metabolites). It confirms that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, expert qualifications, etc.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This means the FDA reviewed data provided by the manufacturer (United Biotech, Inc.) to make the substantial equivalence determination, but the details of those studies are not present in this regulatory letter. To obtain that information, you would typically need to refer to the original 510(k) submission document itself, which is often not publicly available in full detail.

Therefore, I cannot provide the requested information based solely on the provided text.

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THE UBI MAGIWEL™ Amphetamine metabolites is a solid phase enzyme-linked immonosorbent assay(ELISA). This test provides a specific and sensitive assay to qualitatively detect the major amphetamine metabolites in human urine.

solid phase enzyme-linked immonosorbent assay(ELISA)

The provided text does not contain information on the acceptance criteria and study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the UBI MAGIWEL™ Amphetamine Metabolites device, indicating that it has been deemed substantially equivalent to a predicate device. It defines the device and its intended use but does not detail the performance study or specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication method for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
4. Information on a standalone performance study.
5. The type of ground truth used.
6. Sample size for the training set or how its ground truth was established.

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The UBI MAGIWEL™ Cocaine metabolites is a solid phase enzymelinked immunosorbent assay(ELISA). This test kit provides miked innifullosorbent of Cocaine metabolites in human urine. (for Professional use only)

solid phase enzyme-linked immunosorbent assay(ELISA)

The provided document is a 510(k) clearance letter from the FDA for a device called "UBI MAGIWEL™ Cocaine Metabolites." This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, but it does not typically contain the detailed study data, acceptance criteria, or performance metrics that would describe how the device meets specific performance standards.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This means the FDA found the device to be comparable to an existing device, which implies it's expected to perform similarly, but the performance data used to demonstrate this substantial equivalence is usually part of the 510(k) submission itself, not the clearance letter.

Therefore, I cannot extract the requested information from the provided text. The document is an approval letter, not a detailed study report.

To answer your questions, one would need to review the original 510(k) submission (K973156) made by United Biotech, Inc. to the FDA, which would contain the performance data and study details.

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Ask a specific question about this device

Ask a specific question about this device