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The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.

This assay consists of two reagents and a calibrator.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Acetaminophen-SL Assay". This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.

The information required to answer your request, such as detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and detailed performance metrics, is not present within this regulatory letter.

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For the determination of acetaminophen in human serum. Acetaminophen (paracetamol) is used as an analgesic in many different formulations (1). While therapeutic doses rarely cause adverse side effects, the effect of long term treatment with acetaminophen is unclear. Cases have been reported where chronic excessive use of acetaminophen has led to hepatotoxicity and nephrotoxicity (2,3). In cases of acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated (4,5,6).

The management of acetaminophen overdose requires early recognition of the drug in the bloodstream. Toxicity is generally reported at concentrations over 1324 umol/L (20 mg/dL). Nacetylcysteine has been used as an antidote in conjunction with intensive support care. Early diagnosis of acetaminophen-induced hepatotoxicity is important since initiation of therapy within 8 hours of ingestion lessens the potential for hepatic injury, and decreases the mortality rate (7).

For quantitative, in vitro, diagnostic use.

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This document is an FDA 510(k) clearance letter for the "Acetaminophen-SL Assay" and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The letter primarily states that the device has been found substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need access to the actual 510(k) submission or a performance study report for the Acetaminophen-SL Assay.

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