(196 days)
DuPont aca Cholesterol Reagent
DuPont aca Cholesterol Reagent
No
The summary describes a reagent and system based on colorimetric methodology for quantitative determination of cholesterol. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on correlation between the new reagent and a predicate device using standard statistical methods.
No.
The device is described as a reagent used for the quantitative determination of cholesterol, which is a diagnostic tool, not a therapeutic one. It provides information for diagnosis and treatment, but does not directly treat a condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that "Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders." This indicates that the device provides information crucial for diagnosing medical conditions.
No
The device description clearly states it is a "reagent," which is a chemical substance used in a chemical reaction, indicating it is a physical component and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For quantitative determination of cholesterol or HDL cholesterol in plasma or serum." This is a classic example of an in vitro diagnostic test, as it analyzes biological samples (plasma or serum) outside of the body to provide information for diagnosis and treatment.
- Device Description: The description mentions "colormetric methodology," which is a common technique used in laboratory diagnostic tests.
- Performance Studies: The performance studies describe the correlation between this reagent and a predicate device for measuring cholesterol and HDL cholesterol in specimens. This type of study is typical for demonstrating the performance of an IVD.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders'.
Product codes
CHH
Device Description
The Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent are based on colormetic methodology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The correlation between the Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent was demonstrated by assaying 48 specimens using the Paramax® and DuPont aca Systems for Cholesterol. For the HDLC, 100 specimens using Paramax® and DuPont aca Systems were used.
Summary of Performance Studies
The correlation between the Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent was demonstrated by assaying 48 specimens using the Paramax® and DuPont aca Systems. The correlation coefficient for Cholesterol was 0.984, and the regression equation was Paramax® value =(1.10 * aca value) 7.1. For the HDLC, 100 specimens using Paramax® and DuPont aca Systems yielded a correlation coefficient of 0.9881 and a regression equation of Paramax® value = (1.012 * aca value) -2.27.
Key Metrics
Correlation coefficient for Cholesterol was 0.984. Correlation coefficient for HDLC was 0.9881.
Predicate Device(s)
DuPont aca Cholesterol Reagent
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN - 4 1997
510(k) Summary of Safety and Effectiveness Information
The Paramax® Cholesterol Reagent is substantially equivalent to DuPont aca Cholesterol Reagent, which was cleared to. market on unknown. The proposed and the predicate device are intended for use in the quantitative determination of Cholesterol and HDL Cholesterol .
The Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent are based on colormetic methodology.
The technological characteristics of the predicate device are similar to those previously described for the proposed device.
The correlation between the Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent was demonstrated by assaying 48 specimens using the Paramax® and DuPont aca Systems. The correlation coefficient for Cholesterol was 0.984, and the regression equation was Paramax® value =(1.10 * aca value) 7.1. For the HDLC, 100 specimens using Paramax® and DuPont aca Systems yielded a correlation coefficient of 0.9881 and a regression equation of Paramax® value = (1.012 * aca value) The data indicates that the results obtained by both -2.27. reagents are substantially equivalent.
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 4 1997
Marilyn S. Waxburg · Director Requlatory Affairs Dade International, Inc. 9750 N.W. 25th Street Miami, FL 33172
Re :
K964660/S001 Paramax® Cholesterol Reagent Regulatory Class: I Product Code: СНН Dated: March 20, 1997 Received: March 21, 1997
Dear Ms. Waxburg:
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, Druq, 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 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 requlations.
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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 requlation (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 Litman
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
3
Statement of Indications for Use
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510 (k) Number (if known) :
Device Name: Paramax® Cholesterol Reagent 11
Indication(s) for Use:
Intended Use
For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders'.
PLEASE DO NOT WRITE BELOW THIS LINE (CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Prescription Use XX (Per 21 CFR 801.109)
(Optional Format 1-2-96)
OR Over-the-Counter Use
(Division Sign Off)
(Division Sipe -Off) Division of Camell 510(k) Number