(26 days)
Not Found
No
The summary describes a quantitative hemoglobin assay system and does not mention any AI or ML components or capabilities.
No.
The "Intended Use / Indications for Use" section states that the device is "for in-vitro diagnostic use only" for the quantitative determination of hemoglobin, which means it is used to diagnose or monitor a condition rather than treat it.
Yes
The "Intended Use / Indications for Use" states, "The Stat-Site® M Hgb System is for in-vitro diagnostic use only." This explicitly indicates its diagnostic purpose.
No
The summary describes a "Stat-Site® M Hgb System" which includes a "Stat-Site® M Hgb Test Card" and a "Stat-Site® M Hgb meter." This clearly indicates the presence of hardware components (test card and meter) in addition to any potential software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Stat-Site® M Hgb System is for in-vitro diagnostic use only." This is the primary indicator that the device falls under the category of IVDs.
Furthermore, the intended use is for the "quantitative determination of hemoglobin in whole blood," which is a common type of in vitro diagnostic test performed on biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Stat-Site® M Hgb System is for in-vitro diagnostic use only. The Stat-Site® M Hgb Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® M Hgb meter. Target Population: Stat-Site® M Hgb is for use with adults, children, and infants. Environment of Use: Physician's office or other Professional Point of Care setting.
Product codes
KHG
Device Description
Not Found
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
adults, children, and infants
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)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of what appears to be three abstract human figures or forms, stacked vertically.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 1 2002
Richard Tyhach, Ph.D. Vice President, R & D GDS Technology 25235 Leer Drive Elkhart, IN 46514
K020138 Re:
K020130
Trade/Device Name: Stat-Site® M*** System Whole Blood Hemoglobin Assay Regulation Number: 21 CFR 864.7500 Regulation Name: Whole blood hemoglobin assays Regulatory Class: Class II Product Code: KHG Dated: January 15, 2002 Received: January 16, 2001
Dear Dr. Tyhach:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreases 976, the enactment date of the Medical Device Amendments, or to commerco pror to ride 2017 3) in accordance with the provisions of the Federal Food, Drug, devices that hat voon require approval of a premarket approval application (PMA). and Cosmetic (1 tor) the the device, subject to the general controls provisions of the Act. The I ou may, dicrorolo, mainer 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 (PMA), it If your device is elassinod (overal controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of action and i termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I outhall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rate 0773 regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 nredicate 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
D
Enclosure
2
Indications for Use Statement
| 501(k)
| Number : | K020138 |
|---|---|
| Device Name : | Stat-Site® M Hgb System Whole Blood Hemoglobin Assay |
| Indications for | |
| Use: | The Stat-Site® M Hgb System is for in-vitro diagnostic |
| use only. The Stat-Site® M Hgb Test Card is intended for the | |
| quantitative determination of hemoglobin in whole blood. It | |
| is intended for use with the Stat-Site® M Hgb meter. | |
| Target Population: | |
| Stat-Site® M Hgb is for use 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)
Jaychian Bautista.
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K220138
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use _
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