(162 days)
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Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is used for quantitative determination of hemoglobin in blood, which is a diagnostic function, not a therapeutic one.
Yes
The device is used for "quantitative determination of hemoglobin in blood," which is a measurement used to aid in the diagnosis of various medical conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of hemoglobin in blood." This involves testing a sample (blood) taken from the body in vitro (outside the body) to provide diagnostic information (the amount of hemoglobin).
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Biotest Hemoglobin Measuring System fits this description perfectly.
N/A
Intended Use / Indications for Use
The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.
Product codes
GKR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).
0
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 and sides. Inside the circle is a stylized image of an eagle with three lines forming its body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 4 2002
Mr. Mark Licata President Bio.Track LLC 800 East Leigh Street Richmond, Virginia 23219
Re: K020710
Trade/Device Name: Biotest Hemoglobin Measuring System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated Hemoglobin System Regulatory Class: II Product Code: GKR Dated: July 12, 2002 Received: July 12, 2002
Dear Mr. Licata:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 forth in the quality systems (QS) 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 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" (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 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 of
20710 510(k) Number (if known):_ Device Name: BioTEST H&MOglobiN
Indications For Use:
biotrack
Bio•Track LLC 800 Leigh Street Richmond, VA 23219 804/828-9329
February 28, 2002
EXHIBIT D Statement of Intended use
The Biotest Hemoglobin Measuring System is used for quantitative determination of hemoglobin in blood.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Jorphine Boutati
(Divisi
Prescription Use & (Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)