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The Personal Fluid Sample Retrieval System is for over-the-counter distribution and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned directly to the consumer.

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This document is a 510(k) clearance letter from the FDA for a device called "Personal Fluid Sample Retrieval System". It does not contain information about acceptance criteria or specific study details proving a device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

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

The provided text focuses on the regulatory clearance of a medical device and does not include the detailed technical study information required to answer your questions about acceptance criteria and device performance studies.

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The Professional Blood Sample Retrieval System is for use by a medical, dental, chiropractic, podiatric or physician's office and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination to include albumin, alkaline phosphatase, bilirubin, blood urea nitrogen. calcium, chloride, cholesterol, creatinine, gamma-glutamyl transaminase (GGT), globulin, glucose, HDL cholesterol (good), LDL cholesterol (bad), lactic dehydrogenase, phosphorous, potassium, protein - total, sodium, serum gamma-oxaloacetic transaminase (SGOT), serum glutamate-pyruvate transaminase (SGPT), triglycerides, uric acid, lipid panel: cholesterol, HDL (good) cholesterol, LDL (bad) cholesterol, triglycerides; thyroid panel: Thyroxine, Total (T4), triiodothyroxine (T3), thyroid stimulating hormone (TSH): and iron. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned to the ordering physician.

Not Found

This document is a 510(k) clearance letter from the FDA for the "Professional Blood Sample Retrieval System." It is a regulatory document affirming substantial equivalence to a predicate device, not a study report detailing acceptance criteria or device performance data. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.

The document states that the device is for the "collection and transportation of serum for in vitro diagnostic quantitative determination" of various analytes. While it lists the intended use, it does not provide any performance data or acceptance criteria for these determinations.

To answer your questions, I would need a different type of document, such as a clinical study report, a validation report, or a summary of safety and effectiveness data that would typically accompany a 510(k) submission but is not included in this letter.

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