(340 days)
Not Found
No
The device description details a dry-chemistry method and a reflectance colorimeter. The calculation of hemoglobin concentration is based on color intensity measurement, which is a standard photometric technique and does not indicate the use of AI/ML. There is no mention of AI, ML, or related terms in the document.
No
The device is described as an "in vitro diagnostic device only" and is used for "quantitative determination of hemoglobin in whole blood." It does not provide any treatment or therapy to a patient.
Yes
The device is explicitly stated as being for "in vitro diagnostic use only" in the "Intended Use / Indications for Use" section. It quantifies hemoglobin, which is a diagnostic measurement.
No
The device description clearly outlines hardware components: HemoSite® Test Cards (dry-chemistry), a Stat-Site® Meter (reflectance colorimeter), and a Test Module. The software component is part of the Stat-Site® Meter's function to measure color intensity and calculate hemoglobin concentration, but it is integrated with and dependent on the hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "The GDS® HemoSite® Test System is a device for in vitro diagnostic use only." This statement directly identifies the device as an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KHG
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.
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
HemoSite has been evaluated with adults. No samples from neonates, children, or infants were tested at this time.
Intended User / Care Setting
Physician's Office or other Professional Point of Care Setting
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)
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.
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.
Not Found
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
§ 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.
0
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:
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.
Intended 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.
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.
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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