(180 days)
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.
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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.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.