(62 days)
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No
The summary describes a standard in vitro diagnostic test for iron levels and contains no mention of AI or ML.
No
The device is an in vitro diagnostic test system used to measure iron levels, which aids in diagnosis and treatment, but does not itself provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is used for "diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis and chronic renal disease," which directly indicates its diagnostic purpose. It also states "For IN VITRO diagnostic use."
No
The 510(k) summary describes an "iron (non-heme) test system" intended to measure iron in serum and plasma. This strongly implies a physical device that interacts with biological samples (serum and plasma), which is not a software-only medical device. The lack of a "Device Description" section prevents a definitive confirmation, but the intended use points away from a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For the quantitative determination of iron in serum and heparinized plasma." This indicates it's used to analyze biological samples outside of the body.
- "For IN VITRO diagnostic use." This is a direct declaration that the device is intended for in vitro diagnostic purposes.
These statements clearly align with the definition of an IVD, which are medical devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis and chronic renal disease.
For the quantitative determination of iron in serum and heparinized plasma.
For IN VITRO diagnostic use.
Product codes
JIY
Device Description
Iron-PC-SL Assay, Cat. No. 151-10, 151-26
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 862.1410 Iron (non-heme) test system.
(a)
Identification. An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.(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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Olscamp External Regulatory Affairs Coordinator Diagnostic Division Diagnostic Chemical Limited 16 McCarville Street Charlottetown PE Canada C1E 2A6
Re: K020816
Trade/Device Name: Iron-PC-SL Assay Regulation Number: 21 CFR 862.1410 Regulation Name: Iron (non-heme) test system Regulatory Class: Class I Product Code: JIY Dated: March 12, 2002 Received: March 13, 2002
Dear Ms. Olscamp:
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.
MAY 1 4 2002
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 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
Enclosure
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510(K) Notification
Iron-PC-SL Assay, Cat. No. 151-10, 151-26
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Diagnostic Chemicals Limited
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K020816
Device Name: Iron-PC-SL Assay
Indications for Use:
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis and chronic renal disease.
For the quantitative determination of iron in serum and heparinized plasma.
For IN VITRO diagnostic use.
zed plasma.
(Division Sign-Off) Division of Clinical Laboratory Devices 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 .
OR
Over-The-Counter Use
(Per 21 CFR 801.109