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The AST (SGOT) reagents, product No. 117-01 and 117-02 are intended for Invitro determination of AST (SGOT) in serum, or plasma.

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This document is a 510(k) clearance letter from the FDA for a device named "AST (SGOT)". The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing. However, this letter does not contain specific acceptance criteria or details of a study proving the device meets those criteria in the way a clinical trial report or performance study summary would.

Therefore, I cannot provide the requested information from the given text because the document is a regulatory clearance letter, not a detailed performance study report.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: The letter states the device is "substantially equivalent," which is the regulatory hurdle, but doesn't define quantitative performance metrics (like accuracy, sensitivity, specificity, or precision) that would be acceptance criteria, nor does it list the specific results of a study against such criteria.
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size & Ground Truth Establishment: These are all details typically found in a clinical study report or a 510(k) summary (which sometimes includes more detail than the clearance letter itself). This letter only grants clearance based on the submission, it doesn't contain the specifics of that submission's performance data.

The "Indications For Use" section on page 2 simply states the device's intended use: "The AST (SGOT) reagents... are intended for In vitro determination of AST (SGOT) in serum, or plasma." This describes what the device does, not how well it does it or the data proving its performance.

To answer your questions, one would need to review the actual 510(k) submission (including the summary of safety and effectiveness data) that the FDA reviewed to make this substantial equivalence determination, not just the clearance letter.

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For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases.

AST/SGOT LIQUID REAGENT - KINETIC METHOD

The provided document is a 510(k) clearance letter from the FDA for an AST/SGOT Liquid Reagent - Kinetic Method device. This type of document does not typically contain the detailed study information or acceptance criteria as outlined in your request for AI/diagnostic imaging devices.

The 510(k) clearance process demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria in the same way newer, high-risk devices or AI-driven diagnostics do.

Therefore, I cannot extract the specific information you've requested from these pages. The document confirms:

• Device Name: AST/SGOT LIQUID REAGENT - KINETIC METHOD
• Intended Use: "For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases."

To answer your questions about acceptance criteria and study data, one would typically need access to the 510(k) submission document itself, which would include performance data from the manufacturer's internal studies comparing their device to the predicate. This information is not present in the FDA's clearance letter.

Ask a specific question about this device

Ask a specific question about this device