(157 days)
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No
The summary describes a system for hemoglobin analysis using agarose electrophoresis, a traditional laboratory technique. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is used for the qualitative and semi-quantitative determination of abnormal hemoglobins, acting as a screening method for in vitro diagnostic use, which indicates it is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states: "The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer. The system is used as a screening method for in vitro diagnostic use." This explicitly indicates its use for diagnosis.
No
The 510(k) summary describes a "SPIFE Alkaline Hemoglobin system" which is used with a "SPIFE Analyzer" for agarose electrophoresis. This clearly indicates the use of hardware components (the analyzer and the electrophoresis system) and is not a software-only device.
Yes, based on the provided information, the SPIFE Alkaline Hemoglobin system is an IVD (In Vitro Diagnostic) device.
The "Intended Use / Indications for Use" section explicitly states:
- "The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer." This describes a test performed on biological samples (hemoglobin).
- "The system is used as a screening method for in vitro diagnostic use." This directly labels the intended use as "in vitro diagnostic use."
These statements clearly indicate that the device is intended to be used outside of the body to examine samples for diagnostic purposes, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer. The system is used as a screening method for in vitro diagnostic use.
Product codes
JBD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7440 Electrophoretic hemoglobin analysis system.
(a)
Identification. An electrophoretic hemoglobin analysis system is a device that electrophoretically separates and identifies normal and abnormal hemoglobin types as an aid in the diagnosis of anemia or erythrocytosis (increased total red cell mass) due to a hemoglobin abnormality.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/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" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, stacked on top of each other.
DEC 1 7 1998
Ms. Pat Franks Asst. Director, Requlatory Affairs Helena Laboratories 1530 Lindbergh Drive P.O. Box 752 Beaumont, Texas 77704-0752
K982426 Re: SPIFE Alkaline Hemoglobin Kit Trade Name: Regulatory Class: II Product Code: JBD Dated: July 7, 1998 Received: July 13, 1998
Dear Ms. Franks:
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 obliqation 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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, "Misbrandinq 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 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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510(k) Number (if known):
SPIFE Alkaline Hemoglobin Device Name:
Indications for Use:
The SPIFE Alkaline Hemoglobin system is intended for the qualitative and semi-quantitative determination of abnormal hemoglobins using agarose electrophoresis on the SPIFE Analyzer. The system is used as a screening method for in vitro diagnostic use.
Putre Madin'
(Division Sign-Off) Division of Clinical Laboratory Devices K982436 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)