(264 days)
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No
The summary describes a system for collecting and transporting fluid samples for laboratory testing, with no mention of AI or ML in the intended use, device description, or other sections.
No.
The device is described as a "Personal Fluid Sample Retrieval System" for the collection and transportation of serum for in vitro diagnostic quantitative determination of various analytes. Its intended use is for diagnosis and monitoring, not for treating or preventing a disease or condition.
No
The device is described as a "Personal Fluid Sample Retrieval System" for the "collection and transportation of serum for in vitro diagnostic quantitative determination," meaning it collects and transports samples for diagnostic tests, but it does not perform the diagnostic determination itself.
No
The description focuses entirely on a physical system for collecting and transporting a fluid sample (serum) and does not mention any software component or function.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the device is for the "collection and transportation of serum for in vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol." The phrase "in vitro diagnostic" is a direct indicator.
- Purpose: The device is designed to collect a biological sample (serum) that will be used for diagnostic testing outside of the body (in vitro).
- Testing Location: The serum sample is transferred to a "testing laboratory," which is where in vitro diagnostic tests are performed.
Therefore, the primary function of this device is to facilitate an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
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.
Product codes
JKA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Over-the-Counter Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three wave-like lines representing the body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 27 2003
BioMed Personal Metabolic and Nutritional Testing, Inc. c/o Ms. Susan B. Fentress Butler, Snow, O'Mara, Stevens & Cannada, PLLC Cresent Center - Suite 500 6075 Poplar Avenue Memphis, TN 38119
Re: K030394
Trade/Device Name: Personal Fluid Sample Retrieval System Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: September 9, 2003 Received: September 10, 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 your 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 Butman
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: K030394 Device Name: Personal Fluid Sample Retrieval System
Statement of Indications for Use.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-the-Counter Use
| (Optional Format 1-2-9) | V |
|---|---|
| ------------------------------------------------- | --- |
Carol C. Benenati Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030394