The GDS® HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.

Device Description

The HemoSite® Test Cards are dry-chemistry Test Cards that contain chemicals which react and produce color when hemoglobin is present. The Stat-Site® Meter is a reflectance colorimeter that reads color intensity. A Test Module is provided with each box of Test Cards. The Test-Module contains all current calibration information for the specific lot of reagent. The Test Module and Test Cards are coded to each other, and the Stat-Site® Meter will only operate if they are properly matched. HemoSite® Test Cards are dry reagent cards based on the azidemethemoglobin method. When a drop of whole blood is applied to the top of the Test Card, hemolysis occurs, with the release of hemoglobin. Sodium nitrite converts the hemoglobin to methemoglobin. Sodium azide converts methemoglobin to azidemethemoglobin to produce a brown color that is measured at 580 nm using the Stat-Site® Meter. The Stat-Site® Meter measures the color intensity and calculates the hemoglobin concentration.

AI/ML Overview

Here's an analysis of the provided text regarding the HemoSite® Test System, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for the regression analysis or precision. Instead, it presents the results of a comparison study against a predicate device and concludes that the results "compare well." Based on the provided data, we can infer the performance metrics reported.

Acceptance Criteria (Inferred)	Reported Device Performance
Comparison to Predicate Device (Coulter® JT)
- Strong Linear Correlation Coefficient (r) for Venous Blood	Y = 0.90x + 1.3, r = 0.8878
- Strong Linear Correlation Coefficient (r) for Capillary Blood	Y = 1.0x - 0.18, r = 0.8358
Precision (Whole Blood Hemoglobin)
- Low %CV for Within-Run Precision (all hemoglobin levels)	Below 4 %CV
- Low %CV for Total Precision at High Hemoglobin Levels	3.0-3.5 %CV
- Low %CV for Total Precision at Normal Hemoglobin Levels	5.7-5.9 %CV
- Low %CV for Total Precision at Low Hemoglobin Levels	5.9-7.2 %CV
Qualitative Conclusion: Device compares well to predicate.	The data demonstrates that blood hemoglobin results from the Stat-Site®/HemoSite® Test System... compare well to those of laboratory instruments such as the Coulter® JT when determining blood hemoglobin concentrations.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: A total of 212 venous and capillary blood samples were used.
Data Provenance: The samples were obtained internally and at three different physician's office sites. This suggests a blend of controlled laboratory and real-world point-of-care settings. The document does not specify the country of origin, but given the submission is to the FDA, it is highly probable the data is from the United States. The study appears to be prospective in nature, as it describes obtaining samples to compare the new device against a reference method.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The ground truth for this device (hemoglobin concentration) is established by a quantitative measurement from a predicate laboratory instrument, not by expert interpretation.

4. Adjudication Method for the Test Set

This type of information is not applicable to this submission. Adjudication methods are typically used when subjective interpretations (e.g., image readings) require consensus among experts. Here, the comparison is direct quantitative measurement against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This type of study is not applicable to the HemoSite® Test System. This device is a standalone diagnostic test for hemoglobin, not an AI-assisted interpretation system for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The HemoSite® Test System itself is the "algorithm only" in this context. Its quantitative measurements were compared against the established reference method (Coulter® JT) without human interpretation as part of the measurement process. The device's performance (regression statistics and precision) represents its standalone capability.

7. The Type of Ground Truth Used

The ground truth used was measurements from a predicate laboratory instrument: the Coulter® JT hematology analyzer. This is a form of reference standard/comparative method rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This is a 1998 510(k) submission for a diagnostic device that performs a chemical reaction and colorimetry. While the device likely has internal calibration and validation processes (which could be considered analogous to "training" in a very broad sense), the submission focuses on the performance of the final device against a predicate, not on the development of a complex algorithm that requires a distinct, external training set in the modern AI sense. The "Test Module" provided with each box of Test Cards contains "all current calibration information for the specific lot of reagent," implying internal calibration data, but the size or nature of this data is not detailed as a "training set."

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

Since a "training set" in the modern sense of AI/machine learning isn't explicitly described or applicable, the method for establishing its ground truth is also not applicable. The device's function relies on established chemical principles and colorimetric measurement, with calibration data likely derived from known hemoglobin standards.

Summary

{0}------------------------------------------------

K973649

AUG 3 1 1998

HemoSite® Test System 510k Summary

Submitter Identification:

GDS® Diagnostics 25235 Leer Drive Elkhart, IN 46514 Phone: (800) 545-4437 Fax: (219) 262-0109

Jonathan Kovach June 4, 1998

Contact: Date:

Trade Name: Common Name: Classification Name: Comparison Device:

HemoSite® Test Svstem Whole Blood Hemoglobin Test Whole Blood Hemoglobin Determination Coulter® JT (K896873)

Device Description:

Intended Use:

{1}------------------------------------------------

Comparison:

To verify safety and effectiveness of the Stat-Site®/HemoSite® Hemoglobin Test when used under intended use conditions such as a POL setting, the device was compared with the Coulter® JT hematology analyzer. A total of 212 venous and capillary blood samples were obtained internally and at three different physician's office sites. HemoSite® Test System results were compared to the venous blood results from the Coulter® JT reference method. The following regression statistics were obtained: Venous Blood: Y = 0.90x + 1.3, r=0.8878 Capillary Blood: Y = 1.0x - 0.18. r=0.8358

Precision evaluation was performed with whole blood hemoglobin concentrations of 8.7, 13.8 and 18.9 g/dL. All whole blood within-run precision estimates were below 4 %CV. Total precision estimates ranged from 3.0-3.5 %CV at high hemoglobin levels. 5.7-5.9 %CV at normal levels, and 5.9-7.2 %CV at low hemoglobin levels.

Conclusion:

The data demonstrates that blood hemoglobin results from the Stat-Site®/HemoSite® Test System, when used in a point of care setting such as a POL or physician's office, compare well to those of laboratory instruments such as the Coulter® JT when determining blood hemoglobin concentrations.

{2}------------------------------------------------

Image /page/2/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or forms, depicted with flowing lines. The overall design is simple and conveys a sense of unity and service.

AUG 3 1 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Linda Williams Manager of Quality Assurance, Regulatory Affairs GDS TECHNOLOGY, INC. 25235 Leer Drive Elkhart, IN 46514

Re : K973649 Trade Name: HemoSite® Test System Requlatory Class: II Product Code: KHG Dated: June 4, 1998 Received: June 9, 1998

Dear Ms. Williams:

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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlatory 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.

{3}------------------------------------------------

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" (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 Dutman

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

Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is provided.

510(k) Number:	K973649
Device Name:	HemoSite® Test System
Indications for Use:	The GDS® HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.
Targeted population:	HemoSite has been evaluated with adults. No samples from neonates, children, or infants were tested at this time.
Environment of Use:	Physician's Office or other Professional Point of Care Setting

Peter E. Mahurin

Regulation Number and Section

§ 864.7500 Whole blood hemoglobin assays.

(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.