(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.
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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Biomed Personal Metabolic and Nutritional Testing c/o Ms. Susan B. Fentress Butler, Snow, O'Mara, Stevens and Cannada Crescent Center - Suite 500 6075 Poplar Avenue Memphis, TN 38119
JUL 0 7 2003
Re: K030076 Trade/Device Name: Professional Blood Sample Retrieval System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: April 18, 2003 Received: April 21 2003
Dear Ms Fentress:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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APPENDIX A
510(k) Number K030076 Device Name: Professional Blood Sample Retrieval System
Statement of Indications for Use.
Statement of Indications for Use. 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.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
L Prescription Use (per 21 CFR 801.109)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over-the-Counter Use (Optional Format 1-2-9 )
Jean Coopers
Division Sign-Off
Office of In Vitro Diagnostic Devi Evaluation and Safety
510(k) 2030076
§ 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.