(20 days)
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No
The device description details a chemical reaction and spectrophotometric measurement, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is designed to quantitate levels of serum iron and total iron binding capacity in human blood, which is a diagnostic function, not a therapeutic one. It measures a condition rather than treating or preventing it.
Yes
Explanation: The device quantifies serum iron and total iron binding capacity in human blood serum, which are measurements used to diagnose and monitor medical conditions related to iron levels.
No
The device description clearly outlines a chemical assay process involving reagents and spectrophotometric measurement, indicating a hardware-based in vitro diagnostic device, not a software-only device.
Based on the provided information, the CANTROL Serum Iron and Total Iron Binding Capacity test system is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitating the level of serum iron and total iron binding capacity in human blood serum." This involves testing a sample taken from the human body (blood serum) in vitro (outside the body) to provide information about a physiological state.
- Device Description: The description details a chemical reaction that occurs with the serum sample to produce a measurable result (color change). This is a typical characteristic of an IVD test.
- Anatomical Site: The specified anatomical site is "human blood serum," which is a biological sample used for in vitro testing.
Therefore, all the key indicators point to this device being an IVD.
N/A
Intended Use / Indications for Use
CANTROL Serum Iron and Total Iron Binding Capacity test system provides a simple, but effective, method for quantitating the level of serum iron and total iron binding capacity in human blood serum.
Product codes
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Device Description
In the CANTROL Serum Iron procedure Iron is released from its carner, transferrin, by an acidic reagent containing hydroxylamine and thiourea which reduces the iron to its ferrous state. A chromogen reagent, ferene, reacts with the ferrous iron to produce a colored complex, the color of which is proportional to the quantity of Iron in the test sample. Color of the reaction is measured spectrophotometrically. Total Iron Binding Capacity analysis uses the same color reaction to test serum samples which have been saturated with iron by use of an ion exchange resin in the presence of ferric ammonium citrate, prior to the iron determination. The bound iron remaining in the serum after treatment with the resin compound is the Total Iron Binding Capacity.
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
Precision, Linearity and Correlation data is submitted to demonstrate product performance and substantial equivalency with another legally marketed predicate device.
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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§ 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.
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CANYON DIAGNOSTICS,INC.
4075 Leaverton Court · Anaheim, CA 92807 714-632-8711 · FAX 714-632-9407 · 800-445-1146
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food And Drug Administration 9200 Corporate Boulevard Rockville, MD 20850
FEB 11 1997
510(k) Submission Summary
This summary regarding the enclosed 501(k) submission is intended to support safety and effectiveness information in accordance with requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
CANTROL Serum Iron and Total Iron Binding Capacity test system provides a simple, but effective, method for quantitating the level of serum iron and total iron binding capacity in human blood serum. The methods and procedures used in this assay protocol follow well documented, published and accepted methods for determination of the analytes as defined in the 510(k) reference section.
In the CANTROL Serum Iron procedure Iron is released from its carner, transferrin, by an acidic reagent containing hydroxylamine and thiourea which reduces the iron to its ferrous state. A chromogen reagent, ferene, reacts with the ferrous iron to produce a colored complex, the color of which is proportional to the quantity of Iron in the test sample. Color of the reaction is measured spectrophotometrically.
Total Iron Binding Capacity analysis uses the same color reaction to test serum samples which have been saturated with iron by use of an ion exchange resin in the presence of ferric ammonium citrate, prior to the iron determination. The bound iron remaining in the serum after treatment with the resin compound is the Total Iron Binding Capacity.
Precision, Linearity and Correlation data is submitted to demonstrate product performance and substantial equivalency with another legally marketed predicate device.
Submitted by:
Submitted by:
Anthony Palkowski
Anthonv Falkowski Owner Canyon Diagnostics 4075 Leaverton Court Anaheim, CA 92807 (714) 632-8711
Date:
1-17-97