The 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 in a point-of-care setting such as a physician's office or hospital.

Device Description

The HemoSite® Test System is a whole blood hemoglobin measurement device which consists of the Stat-Site® Meter (K911801), HemoSite® Test Card and {lot-specific} HemoSite® Test Module. The test employs dry reagent technology based on the azidemethemoglobin method. The blood sample is applied to one side of the HemoSite® Test Card and the color develops on the opposite side. The color produced is directly proportional to the concentration of hemoglobin in the sample and is read using light reflectance at a specific wavelength; the reflectance reading is performed and reported by the Stat-Site® meter.

AI/ML Overview

The provided text describes the HemoSite® Test System, a whole blood hemoglobin measurement device. Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance (HemoSite® Test System vs. Reference)
Slope	0.9717
Intercept	0.0397
Correlation Coefficient (R)	0.91

Note: The document only provides these three statistical parameters from a regression analysis. It does not explicitly state pre-defined thresholds for "acceptance" for each of these metrics. The conclusion states that the results "compare acceptably with the reference methods," implying that these values were within acceptable limits for FDA clearance.

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

Sample Size: 151 whole blood clinical samples.
Data Provenance: The samples were obtained at 3 independent physician's office sites. This indicates prospective data collection. The country of origin is not explicitly stated, but given the FDA submission, it is highly likely to be the United States.

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

The ground truth was established using a "certified reference standard." The document does not mention the number of experts, their qualifications, or their role in establishing this reference standard. It is implied that the reference standard itself is considered the expert "ground truth."

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by comparison to a "certified reference standard," not through expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The HemoSite® Test System is a device for quantitative determination of hemoglobin, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, this was a standalone performance study. The HemoSite® Test System, which includes the Stat-Site® Meter, HemoSite® Test Card, and Test Module, directly provides the hemoglobin measurement. The study evaluated the performance of this system against a reference standard. There is no mention of human-in-the-loop performance being a variable in the study design.

7. The Type of Ground Truth Used

The ground truth used was a "certified reference standard" for whole blood hemoglobin determination.

8. The Sample Size for the Training Set

The document does not mention a training set. The study described is a clinical validation against a reference standard for the purpose of demonstrating substantial equivalence, not the development or training of a machine learning model.

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

Not applicable, as no training set is mentioned in the document.

Summary

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JAN 1 4 2000

510(k) SUMMARY

Submitter Identification:

GDS® Technology, Inc. 25235 Leer Dr. Elkhart, IN 46514 Phone: (219) 264-7384 Fax: (219) 262-0109

Keith Crawford Director, Quality Assurance / Regulatory Affairs November 30, 1999

HemoSite® Test System Whole Blood Hemoglobin Test Whole Blood Hemoglobin Determination

Contact:

Date:

Trade Name: Common Name: Classification Name:

Comparison Device:

DEVICE DESCRIPTION

INTENDED USE

COMPARISON

To verify the safety and effectiveness of the HemoSite® Test System with infants and children, when used under intended POL use conditions, a total of 151 whole blood clinical samples were obtained at 3 independent physician's office sites. The samples were tested against a certified reference

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standard to determine test performance accuracy. The following combined data regression parameters were obtained:

♦ HemoSite® Test System .vs. Reference Slope= 0.9717 Intercept= 0.0397 Correlation Coefficient= 0.91
Since there are no differences in the product relative to the HemoSite® Test System (K973649), no other product evaluations were required.

CONCLUSION

The clinical data demonstrated that whole blood HemoSite® results with infants and children, when used in a POC setting such as a POL or physician's office, compare acceptably with the reference methods and with the prior Premarket Notification for HemoSite® Hemoglobin Test System, K973649.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

JAN 1 4 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Keith Crawford Director, Regulatory Affairs/Quality Assurance GDS® Technology, Inc. 25235 Leer Drive P.O. Box 473 Elkhart, Indiana 46515

Re: K994073

Trade Name: Hemosite® Test System Regulatory Class: II Product Code: KHG Dated: November 30, 1999 Received: December 2, 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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Page 2

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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):	K994073
Device Name:	Hemosite ® Test System

Indications For Use:

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

Target Popluation:

HemoSite® has been evaluated with adults, children and infants.

Environment of Use:

Physician's Office or other Professional Point of Care setting.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tita E. Huacleri

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994073

Image /page/4/Picture/12 description: The image shows the words "Prescription Use" with a check mark above the word "Use". Below that, it says "(Per 21 CFR 801.109)". The text is in a bold, serif font. The check mark is handwritten.

Over-The-Counter Use

(Optional Format 1-2-96)

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.