(51 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Not Found
This document is a 510(k) clearance letter for the autoHDL™ Cholesterol Reagent Set, which is an in vitro diagnostic device. The letter establishes its substantial equivalence to a legally marketed predicate device. As such, it does not contain the specific technical acceptance criteria or the study details that would typically be found in a performance study report for a novel medical device.
Therefore, many of the requested details about acceptance criteria and study design are not available in the provided text.
Based on the provided text, here's what can be extracted and what information is missing:
-
A table of acceptance criteria and the reported device performance:
- Not Available. The letter grants clearance based on substantial equivalence, implying that the device performance and characteristics are comparable to a predicate device, but it does not detail specific acceptance criteria or performance metrics (like accuracy, precision, linearity, etc.) for the autoHDL™ Cholesterol Reagent Set.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. The letter does not describe any specific test sets or studies performed with the autoHDL™ Cholesterol Reagent Set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable / Not Available. This device is an in vitro diagnostic reagent set. Ground truth for such devices is typically established through reference methods or certified control materials, not expert consensus on images. The document does not provide details on how the performance was verified.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Available. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved. This is not relevant for an in vitro diagnostic device.
-
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:
- Not Applicable / Not Available. MRMC studies are not relevant for this type of in vitro diagnostic reagent. This device is not an AI-assisted diagnostic tool that would involve human reader improvement.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an in vitro diagnostic reagent, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available from the document. For an in vitro diagnostic, ground truth for performance studies typically involves comparison to a recognized reference method or use of certified reference materials with known analyte concentrations. The letter does not specify this.
-
The sample size for the training set:
- Not Applicable. This is a chemical reagent set, not a machine learning algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for a machine learning model is involved.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling a symbol or abstract representation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 5 1999
Mr. William F. Walters, Jr. Vice President - Technical Director Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
Re: K992002
Trade Name: Liquid autoHDL™ Cholesterol Reagent Set Regulatory Class: II Product Code: LBR Dated: June 8, 1999 Received: June 15, 1999
Dear Mr. Walters:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page 1 of 1
510 (k) Number (if known):_ Inknown at this ilmis
Device Name:_autoHDL Cholesterol Reagent Set
Indications for use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
Jean Corpy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K 992002
(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 1-2-96)
§ 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.