(127 days)
For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. High Density Lipoprotein (HDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Not Found
This document is a 510(k) clearance letter for a medical device called the "HDL-ADVANCE Assay." While it confirms FDA clearance based on substantial equivalence to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data typically found in a full submission.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria from this document alone.
Here's what I can tell you based on the provided text, and where the requested information would typically be found in a full 510(k) submission:
Information NOT available in this document:
- A table of acceptance criteria and the reported device performance: This letter only states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide the specific performance data (e.g., accuracy, precision, linearity, analytical sensitivity, specificity) or the acceptance criteria used to assess it. This information would be found in the "Performance Characteristics" section of a detailed 510(k) submission.
- Sample size used for the test set and the data provenance: Not available. This would be part of the study design details in the performance data section.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an in vitro diagnostic (IVD) test for a biomarker. Ground truth for an IVD like an HDL assay is typically established through reference methods or gold standard assays, not expert consensus on images or outcomes.
- Adjudication method for the test set: Not applicable for an IVD for a biomarker.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are typically used for imaging devices where human interpretation is involved.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for an IVD assay. The "device performance" refers to the analytical performance of the assay itself.
- The type of ground truth used: While not explicitly stated, for an HDL assay, the ground truth would typically be established using a recognized reference method for cholesterol or lipoprotein quantification, or by comparing it to an established, FDA-cleared predicate device.
- The sample size for the training set: Not available. For an IVD, "training set" might refer to samples used for method development, calibration, or establishing reference ranges, rather than an ML-specific training set.
- How the ground truth for the training set was established: Not available, but similar to point 7 above, it would involve reference methods or predicate devices.
What this document does tell us:
- Device Name: HDL-ADVANCE Assay, Cat. No. 278-20, 278-50A, 278-50B
- Intended Use/Indications for Use: For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Regulatory Class: Class I (general controls)
- Predicate Device: The substantial equivalence determination is made "to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." The specific predicate device(s) are not identified in this letter, but would be in the full submission.
To get the information you are looking for, you would need to access the full 510(k) submission (K041928), which contains the detailed analytical performance data and studies.
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Public Health Service
2098 Gaither Road Rockville MD 20850
Food and Drug Administration
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, curved shapes, possibly representing human figures or abstract forms. The logo is black and white.
NOV 2 3 2004
Ms. Nancy Olscamp Regulatory Affairs Coordinator, External Diagnostics Chemical Limited 16 McCarville Street Charlottetown, PE Canada C1E 2A6
K041928 Re:
K041928
Trade/Device Name: HDL-ADVANCE Assay, Cat. No. 278-20, 278-50A, 278-50B Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: October 13, 2004 Received: October 14, 2004
Dear Ms. Olscamp:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premaited is substantially equivalent (for the indications
referenced above and have determined the device is subscripes marked in inters referenced above and have determined the devices marketed president devices marketed in interstate for use stated in the encrosule) to regally mancede promises of the Medical Device American son to commerce prior to May 28, 1970, the chacultions of the Federal Food, Drug, devices that have been recults in accordance who f a prevarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval actuals provisions of the Act . and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to urements for annual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the Fectiners and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), p If your device is classified (See above) into enter regulations affecting your device
it may be subject to such additional controls. Existing major regulation Fl it may be subject to such additional controls. "Daising may begins 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Fars 800 to 895. can be found in Title 21, Code of Pederal resguing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualice of a substitute with other requirements of the Act
that FDA has made a determination that your device of the Frequirements of the Act that FDA has made a delermination that your arres by other Federal agencies. You must as and listing or any Federal statures and regulations administered of other to: registration and listing (21
comply with all the Act's requirements, including, but not instruments areastic comply with an the Act s requirements, morants 801 and good manufacturing practice CFR Part 807), labeling (21 CFR Parts 801 and 2017), 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) This letter will allow you to begin makesting your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The PDA Intellig of bassand on 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, a If you desire specific information acount in approvine, please contact the Office of In
or questions on the promotion and advertising of your concess note the or questions on the promotion and activities of your and Safety at (301) 594-3084. Also, please note the Vitro Diagnostic Device Lyanation and Bareey at (30) and Seatings on "C1CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket with and on the regulation entitled, "Misolanding by reference vo presponsibilities under the Act from the You may obtain other general information on your responsible in the sistance 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,
Sincerely yours,
Cornelia B. Parks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number: | K041928 |
|---|---|
| Device Name: | HDL-ADVANCE Assay, Cat. No. 278-20, 278-50A, 278-50B |
| Indications for Use: | For the quantitative determination of high density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. |
A lipoprotein test system is a device intended to measure lipoprotein in serum. High Density Lipoprotein (HDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
പ്പ്-Prescription Use:
And/or
Over-the-Counter Use (OTC): __
(Part 21 CFR 801 Subpart D)
(21 CFR 807 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)
Carol Benam
n Sicin-f
Office of In Vitro Diagnostic Device Evaluation and Satety
510(k) K041928
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.