(242 days)
Not Found
No
The device description details a purely chemical and enzymatic process for measuring LDL-cholesterol, with no mention of computational analysis, algorithms, or learning processes. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device measures LDL-cholesterol levels for diagnosis and treatment planning, but it does not directly treat a condition or restore a bodily function.
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 lipid and lipoprotein metabolism disorders." This directly indicates a diagnostic purpose.
No
The device description clearly outlines a chemical and enzymatic process involving reagents and absorbance measurements, indicating a hardware-based diagnostic system, not software only.
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 LDL-cholesterol in plasma and serum." Plasma and serum are biological samples taken from the human body.
- Diagnostic Purpose: The intended use also states that "Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders." This clearly indicates a diagnostic purpose.
- Device Description: The description details a laboratory procedure involving chemical reagents and enzymatic reactions performed on the biological sample (plasma and serum) to obtain a measurement. This is characteristic of an in vitro diagnostic test.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The Sigma Diagnostics EZ™ LDL- cholesterol test system is a device intended to measure LDL-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.
Product codes
MRR, JIS
Device Description
The Sigma Diagnostics EZ LDL procedure is based on an enzymatic selective protection (ESP) methodology. When a sample is mixed with EZ LDL Reagent 1, the protecting reagent binds to LDL and protects LDL from enzyme reactions. Cholesterol esterase (CHE) and cholesterol oxidase (CO) react with non-LDL lipoproteins (chylomicrons(CM), very low-density lipoprotein (VLDL) and HDL). Hydrogen peroxide produced by the enzyme reactions with non-LDL cholesterol is decomposed by catalase in EZ Reagent 1. When EZ LDL Reagent 2 is added, the protecting reagent is removed from LDL and catalase is inactivated by sodium azide (NaNJ). In this second process, CHE and CO react only with LDL-C. Hydrogen peroxide produced by the enzyme reactions with LDL-C yields a color complex upon oxidase condensation with N-(2hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HDAOS) and 4-aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600 nm, the LDL-C concentration in the sample can be calculated when compared with the absorbance of the LDL-C calibrator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 - 3 2000
Image /page/0/Picture/1 description: The image shows the logo for Sigma Diagnostics. The word "SIGMA" is in large, bold, black letters on the top line. Below that, the word "DIAGNOSTICS" is in smaller, bold, black letters. There is a registered trademark symbol to the right of the word "DIAGNOSTICS".
K 99374//
545 South Fwing Avenue St I ouis MO 63103 L 800-325-0250 · (314) 286-7880 Fax (314) 286-7835 http://www.siama.sial.com/diagnostics.htm
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS EZ LDL-C™ Test System, Procedure 358
Blood total cholesterol levels have long been known to be related to coronary heart disease (CHD). In recent years, in addition to total cholesterol, low density lipoprotein cholesterol (LDL-C) has become an important tool used to assess an individual risk of developing CHD since a strong positive relationship between LDL-C concentration and the incidence of CHD was reported. 1 Thus, there has been substantial interest in LDL-C measurements, and most clinical laboratories routinely perform LDL-C analysis. The currently accepted reference method is generally referred to as "beta quantification, 4" which involves ultracentrifugation. Because this method is labor intensive and technique dependent, it is not generally used for routine testing. The Friedewald formula 3 is most commonly used for routine purposes. However, since the formula estimates LDL-C from measurements of total cholesterol, triglycerides and high-density lipoprotein cholesterol (HDL-C), the LDL-C calculation depends on the accuracy and precision of the three measurements. The EZ LDL Cholesterol test is a homogeneous assay, which eliminates the preparatory steps or calculation, and thus, can be applied on automated analyzers.
The Sigma Diagnostics EZ LDL procedure is based on an enzymatic selective protection (ESP) methodology. When a sample is mixed with EZ LDL Reagent 1, the protecting reagent binds to LDL and protects LDL from enzyme reactions. Cholesterol esterase (CHE) and cholesterol oxidase (CO) react with non-LDL lipoproteins (chylomicrons(CM), very low-density lipoprotein (VLDL) and HDL). Hydrogen peroxide produced by the enzyme reactions with non-LDL cholesterol is decomposed by catalase in EZ Reagent 1. When EZ LDL Reagent 2 is added, the protecting reagent is removed from LDL and catalase is inactivated by sodium azide (NaNJ). In this second process, CHE and CO react only with LDL-C. Hydrogen peroxide produced by the enzyme reactions with LDL-C yields a color complex upon oxidase condensation with N-(2hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HDAOS) and 4-aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600 nm, the LDL-C concentration in the sample can be calculated when compared with the absorbance of the LDL-C calibrator.
The Sigma Diagnostics EZ LDL™ Cholesterol test system (Procedure No. 358) is substantially equivalent to, and are the same product as the Wako Chemical USA, Inc. Direct LDL-C test system cleared by the FDA as K982271.
References
- Burtis CA, Ashwood ER: Ed Teitz Textbook of Clinical Chemistry, 200 Ed, Saunders, 1. Philadelphia, 1994
- Rifai N, Warnick GR, Dominiczak MH: Ed Handbook of Lipoprotein Testing. AACC 2. Press. Washington, DC, USA, 1997
- Friedewald WT, Levy RI, Frederickson DS: Estimation of the concentration of low-న. density lipoprotein cholesterol in plasma without the use of the ultracentrifuge. Clin Chem 18, 449-502, 1972
Sincerely,
Will in the
William R. Gilbert Ph.D. Manager, Scientific Affairs
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 3 2000
William R. Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics, Inc. 545 South Ewing Avenue St. Louis, Missouri 63103
Re: K993741
Trade Name: EZ LDL™ Cholesterol Test System Regulatory Class: I reserved Product Code: MRR Regulatory Class: II Product Code: JIS Dated: May 25, 2000 Received: May 31, 2000
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 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.
2
Page 2
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" (21CFR 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 Butman
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
510(k) Number (if known): _ K99374)
Device Name: EZ LDL™ Cholesterol Test system
Indications For Use:
The Sigma Diagnostics EZ™ LDL- cholesterol test system is a device intended to measure LDL-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.
Looper
(Division Sign-Off)
Division of Clinical Laboratory Devic
510(k) Number K973/41
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _