(186 days)
Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyser. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Not Found
This is a 510(k) clearance letter for the Eon Cholesterol Reagent, an in vitro diagnostic device. This type of document typically provides regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria as might be seen for novel or higher-risk devices, especially those involving AI/ML.
Therefore, the specific information requested in the prompt, especially regarding AI/ML aspects like training sets, expert adjudication, MRMC studies, and standalone performance, is not present in the provided document because it describes a chemical reagent, not an AI/ML device.
However, I can extract what is available about performance and acceptance criteria for this specific type of device.
1. A table of acceptance criteria and the reported device performance
For in vitro diagnostic reagents like the Eon Cholesterol Reagent, acceptance criteria typically involve demonstrating analytical performance characteristics (e.g., accuracy, precision, linearity) that are comparable to a legally marketed predicate device. The document states that the device is "substantially equivalent" to predicate devices, implying that its performance meets the regulatory expectations for such a comparison. However, the specific numerical acceptance criteria (e.g., ±X% accuracy, CV < Y%) and the detailed reported performance data are not provided in this regulatory letter. These details would typically be found in the 510(k) submission document itself, which is not publicly available here.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device for Cholesterol Measurement | Deemed "substantially equivalent" by FDA |
| (Specific analytical performance metrics e.g., accuracy, precision, linearity) | (Not detailed in this document) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the data provenance. For an in vitro diagnostic device, test sets would typically involve patient samples (serum/plasma, as indicated for this device) from various demographic groups, often across different clinical settings. Whether the data was retrospective or prospective is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes a chemical reagent for quantitative determination of cholesterol, not an AI/ML algorithm requiring expert interpretation of images or signals to establish ground truth. The "ground truth" for a cholesterol measurement device would be established by reference methods or highly accurate laboratory instruments, not by human experts adjudicating results in the way machine learning models are evaluated. No information on experts or their qualifications is provided or relevant in this context.
4. Adjudication method for the test set
Not applicable for this type of device (chemical reagent). Ground truth for cholesterol measurement is typically established by established laboratory methods, not by human adjudication of interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study is not relevant for this type of device. MRMC studies are used to evaluate diagnostic imaging systems or AI tools that assist human readers in interpreting complex visual information. The Eon Cholesterol Reagent is an automated in vitro diagnostic test.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is framed for AI/ML algorithms. For a chemical reagent, the "standalone performance" refers to the analytical performance of the assay itself on an automated analyzer. The device described, the "Eon Cholesterol Reagent," is intended for use with the "Eon 100 Clinical Chemistry Analyser," indicating it's an automated test. The performance would be assessed purely through its analytical capabilities, not as an "algorithm only" in the AI sense. The document does not provide the details of this standalone analytical performance, only the FDA's determination of substantial equivalence.
7. The type of ground truth used
For a cholesterol reagent, the ground truth would typically be established by:
- Reference methods: Highly accurate and precise laboratory methods (e.g., isotope dilution mass spectrometry, IDMS) that serve as a gold standard.
- Certified reference materials: Materials with an accurately known concentration of cholesterol.
- Comparison to a legally marketed predicate device: As indicated by the "substantial equivalence" determination, the performance of the Eon Cholesterol Reagent would have been compared to an existing, cleared device, implying that the predicate's results served as a comparison point (though not strictly "ground truth" in the primary sense).
The document itself does not specify which type of ground truth was used for testing.
8. The sample size for the training set
Not applicable. This device is a chemical reagent, not an AI/ML algorithm. There is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the seal is a stylized graphic of three overlapping human figures.
10903 New Hampshire Avenue Silver Spring, MD 20993
Vital Diagnostics Pty Ltd c/o Melita Lambiris 189 - 199 Browns Road Noble Park, Victoria 3174 Australia .
JUL 2 7 2012
Re: K120202
Trade Name: Eon Cholesterol Reagent Regulation Number: 21 CFR §862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets limitations per 21 CFR 862.9(c)(4) Product Codes: CHH Dated: June 13, 2012 Received: June 21, 2012
Dear Melita Lambiris:
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 approval approvisions 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).
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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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Cynthia H. Joiner, Ph.D.
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K120202
Device Name:
Eon Cholesterol Reagent
Indications for Use:
Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyser. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Prescription Use × . (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Q. Rute Chm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 120202
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.