(98 days)
The Piccolo Magnesium Test System used with the Piccolo Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Piccolo Magnesium Test System, which is an in vitro diagnostic device. This type of document typically does not contain detailed information about acceptance criteria, study designs, sample sizes, or ground truth establishment in the way that would apply to AI/ML or imaging devices.
The FDA 510(k) clearance process for in vitro diagnostics usually relies on demonstrating substantial equivalence to a predicate device, which involves analytical performance studies (e.g., accuracy, precision, linearity, interference) rather than clinical outcome studies or expert-based ground truth for image interpretation.
Therefore, many of the specific details requested in your prompt (e.g., test set sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of regulatory document for an in vitro diagnostic test system.
However, I can extract what is explicitly stated or can be inferred:
1. A table of acceptance criteria and the reported device performance:
This information is typically found in the summary of safety and effectiveness, which is not fully included in this clearance letter. The letter confirms substantial equivalence without detailing the specific performance metrics used to establish that.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. Studies for IVDs are typically performed by the manufacturer, but country of origin isn't stated here.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable for an in vitro diagnostic magnesium test. Ground truth for an IVD refers to the correct concentration of the analyte, often determined by a reference method, not by human expert interpretation.
4. Adjudication method for the test set:
This is not applicable for an in vitro diagnostic magnesium test. Adjudication is relevant for subjective assessments, typically in imaging or clinical endpoints.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the Piccolo Magnesium Test System is an automated in vitro diagnostic device, not an AI-assisted imaging or interpretation tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is inherently a "standalone" system in the sense that it performs the
quantitative determination of magnesium without human-in-the-loop interpretation of the result once the sample is loaded. However, this question's phrasing is more suited to AI/ML software. The device itself is the "algorithm," and its performance is determined directly.
7. The type of ground truth used:
For a quantitative diagnostic test like magnesium, the ground truth would typically be established by a reference method or a thoroughly validated, higher-accuracy method of measuring magnesium concentration (e.g., atomic absorption spectroscopy or another established/calibrated clinical chemistry analyzer). The document does not explicitly state the reference method used.
8. The sample size for the training set:
This is not applicable in the context of this device as it's an analytical instrument, not an AI/ML model that learns from a training set in the conventional sense. The "training" for such a device would be its calibration and validation based on chemical and electrical engineering principles, not a data-driven learning process.
9. How the ground truth for the training set was established:
This is not applicable as explained in point 8. The "ground truth" for calibration would be based on certified reference materials or highly accurate standards.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Abaxis, Inc. c/o Mr. Dennis M. Bleile Director of Assay Performance & Compliance 3240 Whipple Road Union City, CA 94587
Re: K091910
Trade name: Piccolo Magnesium Test System Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium Test System Regulatory Class: Class I, reserved Product Code: JGJ Dated: September 23, 2009 Received: September 24, 2009
OCT -1 2009
Dear Mr. Bleile:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{1}------------------------------------------------
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please.contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K091910
Piccolo® Magnesium Test System Device Name: __
Intended Use
The Piccolo Magnesium Test System used with the Piccolo Chemistry Analyzer is intended to be used for the in vitro quantitative determination of magnesium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Indications for Use
and · treatment of the diagnosis Magnesium measurements are used in hypomagnesemia and hypermagnesemia.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K091910 510(k) _______________________________________________________________________________________________________________________________________________________________________
Page 1 of _1
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.