(25 days)
No
The device description details a purely enzymatic and colorimetric method for cholesterol measurement, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic reagent used to quantify cholesterol levels in human samples, which aids in diagnosis and monitoring but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent is for "quantitative, diagnostic determination of cholesterol in human serum and plasma." It further explains that cholesterol levels are used in the "diagnosis and treatment of disorders."
No
The device description clearly outlines a chemical reagent and enzymatic reactions, indicating a physical product used in laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is intended for the "in vitro quantitative, diagnostic determination of cholesterol in human serum and plasma." The phrase "in vitro" means "in glass" or "outside the body," and "diagnostic determination" indicates its use in diagnosing medical conditions.
- Purpose: The text clearly outlines that the measurement of cholesterol levels using this reagent is used in the "diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders." This directly aligns with the purpose of an IVD, which is to provide information for diagnosis, monitoring, or treatment.
- Sample Type: The reagent is designed to be used with "human serum and plasma," which are biological samples taken from the human body.
- Device Description: The description details the enzymatic reactions that occur in vitro to measure cholesterol, further confirming its use outside the body.
Therefore, based on the provided information, the Sigma Diagnostics INFINITY™ Cholesterol Reagent fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum and plasma.
Measurement of serum cholesterol levels can serve as an indicator of liver function, biliary function, intestinal absorption, propensity toward coronary artery disease, thyroid function and adrenal disease. Cholesterol levels are important in the diagnosis and classification of hyperlipoproteinaemias. Stress, age, gender, hormonal balance and pregnancy affect normal cholesterol levels.
Product codes (comma separated list FDA assigned to the subject device)
CHH
Device Description
This reagent is based on the formulation of Allain et al. and the modification of Roeschlau with further improvements to render the reagent stable in solution.
- Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase (CE) to cholesterol and free 1. farry acids. Cholesterol Esters CE Cholesterol + Fatty Acids
- Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase (CO) to 2. cholest-4-en-3-one and hydrogen peroxide .. Cholesterol + O2 _CO _CO _ Cholest-4-en-3-one + H2O2
- The hydrogen peroxide combines with hydroxybenzoic acid (HBA) and 4-aminoantipyrine (AAP) 3. in the presence of peroxidase (POD) to form a chromophore (quinoneimine dye) which may be quantitated at 500-550 nm. For bichromatic analyzers the blank wavelength should be set to 600 or 650 am.
2H2O2 + HBA + 4AAP POD Quinoneimine Dye + 4H2O
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)
Correlation studies to Sigma Diagnostics Cholesterol Reagent, Procedure No. 352 (K872295) using plasma samples yielded a regression equation of:
INFINITY Cholestero] = 1.00 (Cholesterol 352) - 0.3 (N=126)
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.
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.
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
§ 862.1175 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.
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SEP 1 3 1999 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFINITYTM Cholesterol Reagent, Procedure 401
Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum and plasma.
Measurement of serum cholesterol levels can serve as an indicator of liver function, biliary function, intestinal absorption, propensity toward coronary artery disease, thyroid function and adrenal disease. Cholesterol levels are important in the diagnosis and classification of hyperlipoproteinaemias. Stress, age, gender, hormonal balance and pregnancy affect normal cholesterol levels. 12
This reagent is based on the formulation of Allain et al. and the modification of Roeschlau with further improvements to render the reagent stable in solution.
- Cholesterol esters are enzymatically hydrolyzed by cholesterol esterase (CE) to cholesterol and free 1. farry acids. Cholesterol Esters CE Cholesterol + Fatty Acids
- Free cholesterol, including that originally present, is then oxidized by cholesterol oxidase (CO) to 2. cholest-4-en-3-one and hydrogen peroxide .. Cholesterol + O2 _CO _CO _ Cholest-4-en-3-one + H2O2
- The hydrogen peroxide combines with hydroxybenzoic acid (HBA) and 4-aminoantipyrine (AAP) 3. in the presence of peroxidase (POD) to form a chromophore (quinoneimine dye) which may be quantitated at 500-550 nm. For bichromatic analyzers the blank wavelength should be set to 600 or 650 am.
2H2O2 + HBA + 4AAP POD Quinoneimine Dye + 4H2O
The Sigma Diagnostics INFINITY™ Cholesterol Reagent Kit (Procedure No. 401) is substantially equivalent to, and is the same product as the TRACE Scientific Cholesterol Reagent Kit cleared by FDA as K962890.
Correlation studies to Sigma Diagnostics Cholesterol Reagent, Procedure No. 352 (K872295) using plasma samples yielded a regression equation of:
INFINITY Cholestero] = 1.00 (Cholesterol 352) - 0.3 (N=126)
References
- Searcy R.L. "Diagnostic Biochemistry." McGraw-Hill, New York, NY. 1969. 1.
- Ellefson R.D. and Caraway W.T. "Fundamentals of Clinical Chemistry." Ed. Tictz N.W. 1976; p 2. રેણવાડી રહ્યારે તે અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને પાસની દર્ભાગના પાસની દર્ભાગના દિવસ દિવસ દિવસ દિવસ
- Allain C.C., Poon L.S., Chan C.S.G., Richmond W. and Fu P.C. Clin. Chem., 1974; 20:470-475. 3. .
- Roeschlau P., Bernt E. and Gruber W.A. Clin. Chem. Clin. Biochem. 1974; 12:226. 4.
Contact Person:
William R. Gilbert II, Ph.D. Manager, Scientific Affairs Sigma Diagnostics 545 South Ewing St. Louis, MO 63103 314-286-6693
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.
SEP 1 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William R. Gilbert, Ph.D. Manager, Scientific Affairs SIGMA DIAGNOSTICS® 545 South Ewing Avenue St. Louis, Missouri 63103
K992803 Re:
Trade Name: INFINITY™ CHOLESTEROL Reagent (Procedure No. 401) Regulatory Class: I reserved Product Code: CHH Dated: August 16, 1999 Received: August 19, 1999
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.
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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/cdrl/dsma/dsmamain.html".
Sincerely yours.
Steven Putman
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):
Device Name: Sigma Diagnostics INFINITY™ Cholesterol Reagent
Indications For Use:
.
Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum or plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
Seán Cogger
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices 510(k) Number .
(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 _