(56 days)
The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.
Not Found
This communication is an FDA 510(k) clearance letter for the HDLC Precipitating Reagent. It does not contain the detailed study information generally associated with acceptance criteria and device performance evaluation. The letter indicates that the device has been found substantially equivalent to a predicate device, which means its safety and effectiveness have been deemed comparable to a previously cleared device. However, the letter itself does not provide the specific data from the studies that supported this determination.
Therefore, most of the requested information cannot be extracted from this document alone. For a comprehensive answer, information from the original 510(k) submission (K982539) would be required.
Based only on the provided text, here's what can be inferred or stated as missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document is a clearance letter, not a performance report. It states the device is "substantially equivalent" but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is part of the original 510(k) submission, not the clearance letter.
3. 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)
- Cannot be extracted. This information would be found in the detailed study protocol and results of the 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. This information would typically be described in the study design section of the 510(k) submission.
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
- Not applicable / Cannot be extracted. This is a reagent (HDLC Precipitating Reagent) used in a clinical laboratory setting, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies and "human readers improve with AI" metrics are not relevant to this type of product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Cannot be extracted. This is a laboratory reagent. The concept of "standalone algorithm performance" without human-in-the-loop is not relevant here. The device's performance would be measured by its accuracy in separating HDL from other lipoproteins, which then informs a diagnostic interpretation by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. For a precipitating reagent, the "ground truth" would likely involve comparison against established reference methods or highly accurate analytical techniques for lipoprotein separation and quantification. However, this detail is not in the clearance letter.
8. The sample size for the training set
- Not applicable / Cannot be extracted. A "training set" is typically associated with machine learning or AI models. This is a chemical reagent, so this concept does not apply in the same way. Performance studies would involve method validation, accuracy, precision, and interference studies.
9. How the ground truth for the training set was established
- Not applicable / Cannot be extracted. See explanation for #8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 5 1998
Charles C. Allain, Ph.D. . AC Biochemicals, Inc. 17955 Sky Park Circle, Suite J Irvine, California 92614
K982539 Re : HDLC Precipitating Reagent Requlatory Class: I Product Code: LBS Dated: July 14, 1998 Received: July 21, 1998
Dear Dr. Allain:
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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.
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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/dsmamain.html".
Sincerely yours,
Steven Gutman
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
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510(k) K964917:
ﻣﺤﻤﺪ ﺳ
Device Name: HDLC Precipitating Reagent
Indications For Use:
The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 12 982539
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use Use(Per 21 CFR 801.109) |
|---|
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OR
Over-The-Counter
§ 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.