(43 days)
Not Found
None
No
The summary describes a chemical reagent kit for laboratory testing and contains no mention of AI or ML.
No
The device is described as reagents (Buffer, pH 4.5 and Color reagent) for the "automated, quantitative determination of Total Iron in serum, or plasma." This indicates a diagnostic purpose (measuring a substance in the body), not a therapeutic one (treating or alleviating a disease/condition).
Yes
The device is described as "reagents ... intended for use in the automated, quantitative determination of Total Iron in serum, or plasma," which directly aligns with the definition of a diagnostic device that measures substances in biological samples to aid in diagnosis.
No
The device description is not found, but the intended use clearly describes "reagents" (Buffer and Color reagent) which are physical substances used in a chemical reaction to determine Total Iron. This indicates the device involves hardware components (the reagents themselves) and is not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of Total Iron in serum, or plasma." Serum and plasma are biological specimens taken from the human body.
- In Vitro: The determination of the analyte (Total Iron) is performed in vitro (outside of the living organism) using reagents.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information clearly aligns with this definition.
N/A
Intended Use / Indications for Use
The total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, The lotal non reagents. Dance, pro no (201) productio use in the automated, quantitative determination of Total Iron in serum, or plasma.
Product codes
JMO
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human figures in profile, arranged in a row. The figures are connected by a flowing line that resembles a ribbon or wave. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAY 25 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
A.P. Total Care, Inc. Luis P. Leon c/o Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, CT
Re: K991244 Trade Name: Total Iron Requlatory Class: II Product Code: JMO April 07, 1999 Dated: April 12, 1999 Received:
Dear Mr. Leon:
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 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 In addition, FDA may publish further regulatory action. 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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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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_1_of_1
| 510(k) Number (if known): | K991244 |
|---|---|
| Device Name: | TOTAL IRON |
Indications For Use:
The total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, The lotal non reagents. Dance, pro no (201) productio use in the automated, quantitative determination of Total Iron in serum, or plasma.
Jean Coogr
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K991244
(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)