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.

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,

AI/ML Overview

CholeSite® Test System: Acceptance Criteria and Performance Study Summary

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the CholeSite® Test System. However, the study aims to demonstrate acceptable comparison with established reference methods. We can infer the performance metrics reported are intended to show this acceptability.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance
Correlation to Abell-Kendall	High correlation desired	Slope = 1.192, Intercept = 27.94, Correlation Coefficient (R) = 0.96
Correlation to COBAS Bio Reference	High correlation desired	Slope = 1.000, Intercept = 0.91, Correlation Coefficient (R) = 0.9437
Precision (Total CV)	Low CV desired	Below 5.4% (at 135 and 300 mg/dL cholesterol concentrations)
Individual Meter Precision (CV)	Low CV desired	No single Meter having CVs above 4.2% (at 135 and 300 mg/dL cholesterol concentrations)

2. Sample Sizes and Data Provenance for Test Set

Clinical Samples:
- Venous whole blood: 148 samples
- Capillary whole blood: 148 samples
- Provenance: Obtained at 3 different physician's office sites (Prospective, US-based as per FDA context).
In-House Samples:
- Venous whole blood: 40 samples
- Capillary whole blood: 40 samples
- Provenance: In-house testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The study does not mention the use of "experts" in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth for the test set was established by established laboratory methods and reference instruments. Therefore, the concept of "number of experts" and "qualifications of experts" as typically applied to image interpretation or clinical diagnosis does not directly apply here. The expertise lies in the validated methodologies and operation of the reference instruments.

4. Adjudication Method for Test Set

Not applicable. The ground truth was established by direct measurement using reference standard methodologies and instruments, not through expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a study evaluating a diagnostic device for total cholesterol measurement against laboratory reference methods, not an AI-assisted interpretation system for human readers. Therefore, an MRMC study and the concept of "human readers improve with AI vs without AI assistance" are not relevant here.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance study was conducted. The CholeSite® Test System, which includes the Test Card, Test Module, and Stat-Site® electronic reflectance photometer (Meter), performed the measurements and generated the cholesterol concentration values independently of human interpretation influence. Its performance was then compared directly to the reference methods.

7. Type of Ground Truth Used

Two types of ground truth were used:

Abell-Kendall Reference Standard Methodology: This is described as the "industry 'gold standard' cholesterol test reference method." This represents a highly accurate and established laboratory method.
COBAS Bio Reference (GDS® reference method): This was used for in-house testing and serves as another established laboratory reference instrument for cholesterol determination.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or a machine learning model being trained. The CholeSite® Test System appears to be a dry reagent technology with a photometric measurement system, implying that its underlying principles are based on known biochemical reactions and calibration, rather than a data-driven machine learning model requiring a large training dataset in the conventional sense. If any form of calibration or internal adjustment was performed, the data used for that is not specified as a "training set."

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, a "training set" in the context of machine learning is not explicitly mentioned or implied. The system's operation is based on biochemical reactions and a calibrated photometer. Any initial calibration or validation would likely have used commercially available reference standards or samples analyzed by established laboratory methods. However, the details of such a process are not provided or referred to as a "training set."

Summary

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KG92.132

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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

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

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Indications for Use Statement

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Device Name: CholeSite® Test System

Indications for Use:

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

page 54 of 54

Regulation Number and Section

§ 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.