(58 days)
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No
The device description details a chemical reaction and reflectance photometry to measure cholesterol, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is an in vitro diagnostic product used for the quantitative determination of total cholesterol, which is for diagnostic purposes, not for treating or rehabilitating patients.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The GDS® CholeSite® Test System is an in vitro diagnostic product for the quantitative determination of total cholesterol in whole blood."
No
The device description explicitly includes hardware components: a Test Card, Test Module, and a hand-held Stat-Site® electronic reflectance photometer (Meter). The software is part of a larger system that includes physical components for sample analysis.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The GDS® CholeSite® Test System is an in vitro diagnostic product for the quantitative determination of total cholesterol in whole blood."
N/A
Intended Use / Indications for Use
The CholeSite® Test System is a blood cholesterol screening device used for the quantitative determination of total cholesterol in whole blood and, thereby, producing a plasma equivalent result. This test system is to be utilized in a point-of-care setting such as a physician's office or hospital point-of-care site.
The GDS® CholeSite® Test System is an in vitro diagnostic product for the quantitative determination of total cholesterol in whole blood. It is intended for the sole use with the GDS® Stat-Site® Meter.
Product codes
CHH
Device Description
This whole blood cholesterol test system consists of a CholeSite® Test Card, Test Card specific Test Module, and the hand-held Stat-Site® electronic reflectance photometer (Meter), The test methodology employs a dry reagent technology based on the cholesterel esterase method. When a drop of whole blood is applied to the top opening on the Test Card. The cholesters present in the patient's blood sample are hydrolyzed by cholesterol esterase. The free cholesterol is then oxidized by cholesterol oxidase, producing hydrogen peroxide, which substantially reacts with TOOS in a reaction catalyzed by peroxidase to produce a colored compound on the bottom of the Test Card. The Stat-Site® Meter, using reflectance at 660 nm, measures the color characteristics produced and converts the reflectance reading to a correlated cholesterol concentration value,
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The targeted population for the CholeSite® Test System is adults.
Intended User / Care Setting
The environment of use are Physician Office Laboratories and other Professional Point of Care settings.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To verify safety and effectiveness of the CholeSite® Test System when used under intended POL use conditions, the device was compared to the Abell-Kendall industry "gold standard" cholesterol test reference method. A total of 148 venous whole blood clinical samples and 148 capillary whole blood dinical samples were obtained at 3 different physician's office sites. Additionally, in-house testing was performed using 40 venous whole blood samples and 40 capillary whole blood samples and then tested against the GDS® reference method (COBAS) using plasma from the same blood samples. The following regression parameters were obtained:
CholeSite® Test System .vs. Abell-Kendall (clinical) Slope= 1.192 Intercept= 27.94 Correlation Coefficient (R)= 0.96
CholeSite® Test System .vs. COBAS Bio Reference (in-house) Slope= 1.000 Intercept= 0.91 Correlation Coefficient (R)= 0.9437
A precision evaluation was performed at cholesterol concentrations of 135 and 300 mg/dL on three Stat-Site® Meters. Total CV5 were below 5,4%, with no single Meter having CV8 above 4,2%; therefore, demonstrating comparable performance of the CholeSite® Test System against the COBAS analyzer used as an in-house reference.
The data demonstrated that whole blood cholesterol results using the CholeSite® Test System, when used in a POC setting such as a POL or physician's office, compare acceptably with the Abell-Kendall and Follas reference methods. Likewise, reference whole blood samples compared acceptably with standard, in-house testing reference equipment (COBAS).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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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KG92.132
Image /page/0/Picture/1 description: The image is a black and white graphic that appears to be a logo or emblem. It features a stylized shape, possibly representing an object or figure, with bold black outlines and white spaces within. There is some text or a signature incorporated into the design, adding a personal or identifying element to the overall image.
So Technology, Inc.
Office: (219) 264-7 FAX: (219) 262-0109
AUG 20 1999
510(k) SUMMARY
Submitter Identification:
GDS® Technology, Inc. 25235 Leer Dr. Elkhart, IN 46514 Phone: (219) 264-7384 Fax: (219) 266-0062
Keith Crawford June 18, 1999
CholeSite® Test System Whole Blood Cholesterol Test System Whole Blood Total Cholesterol Determination
Abell-Kendall Reference Standard Methodology
Contact: Date:
Trade Name: Common Name: Classification Name:
Comparison Device:
DEVICE DESCRIPTION
This whole blood cholesterol test system consists of a CholeSite® Test Card, Test Card specific Test Module, and the hand-held Stat-Site® electronic reflectance photometer (Meter), The test methodology employs a dry reagent technology based on the cholesterel esterase method. When a drop of whole blood is applied to the top opening on the Test Card. The cholesters present in the patient's blood sample are hydrolyzed by cholesterol esterase. The free cholesterol is then oxidized by cholesterol oxidase, producing hydrogen peroxide, which substantially reacts with TOOS in a reaction catalyzed by peroxidase to produce a colored compound on the bottom of the Test Card. The Stat-Site® Meter, using reflectance at 660 nm, measures the color characteristics produced and converts the reflectance reading to a correlated cholesterol concentration value,
INTENDED USE
The CholeSite® Test System is a blood cholesterol screening device used for the quantitative determination of total cholesterol in whole blood and, thereby, producing a plasma equivalent result. This test system is to be utilized in a point-of-care setting such as a physician's office or hospital point-of-care site.
COMPARISON
To verify safety and effectiveness of the CholeSite® Test System when used under intended POL use conditions, the device was compared to the Abell-Kendall industry "gold standard" cholesterol test reference method. A total of 148 venous whole blood clinical samples and 148 capillary whole blood dinical samples were obtained at 3 different physician's office sites. Additionally, in-house testing was performed using 40 venous whole blood samples and 40 capillary whole blood samples
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and then tested against the GDS® reference method (COBAS) using plasma from the same blood samples. The following regression parameters were obtained:
- · CholeSite® Test System .vs. Abell-Kendall (clinical) Slope= 1.192 Intercept= 27.94 Correlation Coefficient (R)= 0.96
- · CholeSite® Test System .vs. COBAS Bio Reference (in-house) Slope= 1.000 Intercept= 0.91 Correlation Coefficient (R)= 0.9437
A precision evaluation was performed at cholesterol concentrations of 135 and 300 mg/dL on three Stat-Site® Meters. Total CV5 were below 5,4%, with no single Meter having CV8 above 4,2%; therefore, demonstrating comparable performance of the CholeSite® Test System against the COBAS analyzer used as an in-house reference.
CONCLUSION
The data demonstrated that whole blood cholesterol results using the CholeSite® Test System, when used in a POC setting such as a POL or physician's office, compare acceptably with the Abell-Kendall and Follas reference methods. Likewise, reference whole blood samples compared acceptably with standard, in-house testing reference equipment (COBAS).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 20 1999
Mr. Keith Crawford Director, Regulatory Affairs / Quality Assurance GDS Technology, Inc. - 25235 Leer Drive P.O. Box 473 * Elkhart, Indiana 46515
K992132 Re:
Trade Name: CholSite®Test System Regulatory Class: I reserved Product Code: CHH Dated: June 18, 1999 Received: June 23, 1999
Dear Mr. Crawford:
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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
4
Indications for Use Statement
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name: CholeSite® Test System
Indications for Use:
The GDS® CholeSite® Test System is an in vitro diagnostic product for the quantitative determination of total cholesterol in whole blood. It is intended for the sole use with the GDS® Stat-Site® Meter.
Targeted Population:
The targeted population for the CholeSite® Test System is adults.
Environment of Use:
The environment of use are Physician Office Laboratories and other Professional Point of Care settings.
(Division Sign-Off) acting Branch Chief, Lola DeCope
Division of Clinical Laboratory Devices
510(k) Number 7762432
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