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SYSCON IDC-G is a human serum based unassayed control used to monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens. These controls are to be used with in vitro immunoassay procedures for the qualitative determination of Chlamydia, Epstein-Barr related antigen, Borrelia burgdorferi, Herpes Complex, Hepatitis, and TORCH. These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors.

SYSCON IDC-G, NEGATIVE AND POSITIVE is a human serum based unassayed control.

The provided text is a scanned FDA 510(k) clearance letter and an Indications for Use statement for the "SYSCON IDC-G, NEGATIVE AND POSITIVE" device. This type of document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.

The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The Indications for Use describe what the device is for (monitoring analytical procedures and reagents for detecting infectious disease agents in patient serum or plasma) but does not include any performance metrics or study data.

Therefore, I cannot provide the requested table and information based on the given text.

To answer the user's request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed product manual that includes performance data.

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