(50 days)
Not Found
Not Found
No
The device description details a chemical reaction and spectrophotometric measurement for determining HDL-C concentration. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended to measure HDL cholesterol for diagnosis and treatment of disorders, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to measure HDL cholesterol in plasma and serum" and that "Cholesterol measurements and HDL cholesterol measurements are used in the diagnosis and treatment of disorders of lipid and lipoprotein metabolism." This indicates its role in aiding diagnosis.
No
The device description clearly outlines a chemical reagent and calibrator system that utilizes enzymatic reactions and colorimetric measurements, indicating a hardware-dependent laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure HDL cholesterol in plasma and serum" and that these measurements are "used in the diagnosis and treatment of disorders of lipid and lipoprotein metabolism." This clearly indicates a medical purpose for analyzing samples taken from the human body.
- Device Description: The description details a chemical reaction that occurs with a biological sample (plasma and serum) to produce a measurable result (color complex with absorbance). This is characteristic of an in vitro diagnostic test.
- Calibrator: The inclusion of a calibrator "intended for medical purposes for use in a HDL cholesterol test system to establish points of reference that are used in the determination of values in the measurement of HDL cholesterol in plasma and serum" further confirms its role in a diagnostic testing system.
- Intended User: The intended user is "Clinical laboratories," which are settings where in vitro diagnostic testing is performed.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sigma Diagnostics EZ HDL™ Reagent (Presedure 354).is a device intended to relations HDL cholesterol in plasma and serum. Cholesterol in the bl mail Diagnostics EZ HDL™ Reagent (Procedure 354) is a device internetits are used mesure HDL cholesterol in plasma and serum. Cholesterol in the blood Sigma Diagnostics E2 HDL - Rought (Cholesterol measurements and assurements and assure HDL and are also measure HDL cholesterol in plasma and serum. in the Maso mediation in the diagnosis and treatment of disorders. and lipid and lipoprotein metabolism disorders.
Sigma Diagnostics EZ HDL™ Calibrator (354-5) is a device intended for medical Sigma Crimes in a HDL cholesterol test system to establish po Sigma Diagnostics EZ HDL™ Calibrator (354-5) is a device intentional of reference that purposes for use in a HDL cholesterol test system to establish points of reference that Sigma Diagnostics L.2 112 purposes for use in a HDL cholesterol test system to establish politics of virus of virus are used in the determination of values in the measureme are assessmens.
Product codes (comma separated list FDA assigned to the subject device)
LBS, JIS
Device Description
Blood total cholesterol levels have long been known to be related to coronary heart disease (CHD). In recent years, in addition to total cholesterol, high dcnsity lipoprotein cholesterol (HDL-C) has become an important tool used to assess an individual risk of developing CHD since a strong negative relationship between HDL-C concentration and the incidence of CHD was reported. Thus, there has been substantial interest in HDL-C measurements, and most clinical laboratories routinely perform HDL-C analysis. Selective chemical precipitation techniques are widely used for the determination of HDL-C such as heparinmanese, dextran sulfate-magnesium, and phosphotungstate-magnesium2 However, these techniques require physical separation via centrifugation, which is not suited to large scale lab use.
Anti human B-lipoprotein antibody in Reagent 1 binds to lipoproteins (LDL, VLDL, and chylomicrons) other than HDL. The antigen-antibody complexes formed block enzyme reactions when Reagent 2 is added. Cholesterol esterase (CHE) and cholesterol oxidase (CO) in Reagent 2 react only with HDL-C. Hydrogen peroxide produced by the enzyme reactions with HDL-C yields a blue color complex upon oxidase condensation with FDAOS and 4-aminoantipyrine (4AA) in the presence of peroxidase (POD), By measuring the absorbance of the blue color complex produced, at approximately 600nm, the HDL-C concentration in the sample can be calculated with the absorbance of the EZ HDL™ Calibrator.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the Sigma Diagnostics EZ HDL™ Cholesterol Reagent, Procedure 354 is demonstrated by its substantial equivalency to a Cholesterol Reference Method Laboratory Network standardized 50K molecular weight Dextran Sulphate precipitation method. Both HDL test systems are used to measure HDL-C concentrations in serum and plasma. In comparison studies against this Dextran Sulphate mcthod, a correlation coefficient of 0.980 and regression equation y = 0.82x + 7.48 were obtained with 97 serum samples. In additional comparison studies against the Sigma Diagnostics 352-7 Phosphotungstic Acid procedure, a correlation cocflicient of 0.990 and regression equation y = 0.97x +5.07 were obtained. Within run precision and total precision on serum samples indicate acceptable values can be replicated on a day to day basis. Sigma Diagnostics EZ HDL™ Cholesterol Reagent has been determined to be linear to 180 mg/dL and can be used with samples with triglyceride concentrations up to 2100 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
JUL 22 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
EZ HDLTM CHOLESTEROL, PROCEDURE NO. 354
Blood total cholesterol levels have long been known to be related to coronary heart disease (CHD). In recent years, in addition to total cholesterol, high dcnsity lipoprotein cholesterol (HDL-C) has become an important tool used to assess an individual risk of developing CHD since a strong negative relationship between HDL-C concentration and the incidence of CHD was reported. Thus, there has been substantial interest in HDL-C measurements, and most clinical laboratories routinely perform HDL-C analysis. Selective chemical precipitation techniques are widely used for the determination of HDL-C such as heparinmanese, dextran sulfate-magnesium, and phosphotungstate-magnesium2 However, these techniques require physical separation via centrifugation, which is not suited to large scale lab use.
Anti human B-lipoprotein antibody in Reagent 1 binds to lipoproteins (LDL, VLDL, and chylomicrons) other than HDL. The antigen-antibody complexes formed block enzyme reactions when Reagent 2 is added. Cholesterol esterase (CHE) and cholesterol oxidase (CO) in Reagent 2 react only with HDL-C. Hydrogen peroxide produced by the enzyme reactions with HDL-C yields a blue color complex upon oxidase condensation with FDAOS and 4-aminoantipyrine (4AA) in the presence of peroxidase (POD), By measuring the absorbance of the blue color complex produced, at approximately 600nm, the HDL-C concentration in the sample can be calculated with the absorbance of the EZ HDL™ Calibrator.
The safety and effectiveness of the Sigma Diagnostics EZ HDL™ Cholesterol Reagent, Procedure 354 is demonstrated by its substantial equivalency to a Cholesterol Reference Method Laboratory Network standardized 50K molecular weight Dextran Sulphate precipitation method. Both HDL test systems are used to measure HDL-C concentrations in serum and plasma. In comparison studies against this Dextran Sulphate mcthod, a correlation coefficient of 0.980 and regression equation y = 0.82x + 7.48 were obtained with 97 serum samples. In additional comparison studies against the Sigma Diagnostics 352-7 Phosphotungstic Acid procedure, a correlation cocflicient of 0.990 and regression equation y = 0.97x +5.07 were obtained. Within run precision and total precision on serum samples indicate acceptable values can be replicated on a day to day basis. Sigma Diagnostics EZ HDL™ Cholesterol Reagent has been determined to be linear to 180 mg/dL and can be used with samples with triglyceride concentrations up to 2100 mg/dL.
REFERENCES
- Rifai N. Warnick GR, Ed. Laboratory Measurement of Lipids, Lipoproteins and Apolipoproteins. AACC Press, Washington, DC, USA, 1994
Burtis CA, Ashwood ER, Ed. Tietz Textbook of Clinical Chemistry, 2nd ed., Saunders, 2. Philadelphia, 1994
Date of Preparation: July 1997 Contact: William R. Gilbert (314) 771-3122
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 2 1997
William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics …… 545 South Ewinq Avenue St. Louis, Missouri 63103
K972041 Re : EZ HDL™ Cholesterol Reagent/Calibrator Requlatory Class: I & II Product Code: LBS, JIS May 30, 1997 Dated: Received: June 2, 1997
Dear Dr. Gilbert:
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 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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.
2
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 ene regaracion enorification" (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
~ Page_1_of _1__1__1__1
K.972041
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
s 10(k) Number (il Known).
Indications For Use:
Indications FOT USC.
Sigma Diagnostics EZ HDL™ Reagent (Presedure 354).is a device intended to
relations HDL cholesterol in plasma and serum. Cholesterol in the bl mail Diagnostics EZ HDL™ Reagent (Procedure 354) is a device internetits are used
mesure HDL cholesterol in plasma and serum. Cholesterol in the blood Sigma Diagnostics E2 HDL - Rought (Cholesterol measurements and assurements and assure HDL and are also
measure HDL cholesterol in plasma and serum. in the blood
in the Maso mediation in the diagnosis and treatment of disorders.
and lipid and lipoprotein metabolism disorders.
and lipid and lippyrotein micals .
Sigma Diagnostics EZ HDL™ Calibrator (354-5) is a device intended for medical
Sigma Crimes in a HDL cholesterol test system to establish po Sigma Diagnostics EZ HDL™ Calibrator (354-5) is a device intentional of reference that
purposes for use in a HDL cholesterol test system to establish points of reference that Sigma Diagnostics L.2 112 purposes for use in a HDL cholesterol test system to establish politics of virus of virus
are used in the determination of values in the measureme are assessmens.
(Division Sign-Off)
Division of Clinical Laboratory Device
510(k) Number. K92041
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(PLEASE DO NOT WRITE BEI.OW THIS LINE-CONTINUE ON CONSULTION (CODE)
NOT WRITE BE...
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use __________