(24 days)
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No
The summary describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
This device is a control material used for quality control in laboratory testing of Serum Iron and Total Iron Binding Capacity, not for treating a patient.
No
The device is described as a control material used for quality control in the quantitation of Serum Iron and Total Iron Binding Capacity, not for diagnosing diseases or conditions.
No
The device description clearly states the product is manufactured from human serum and is a control material, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used for "quality control in the quantitation of Serum Iron and Total Iron Binding Capacity." These are laboratory tests performed on biological samples (serum) to provide information about a patient's health status.
- Device Description: The device is "manufactured from human serum" and is used "in a manner identical to patient samples" for "monitoring Serum Iron and TIBC testing procedures." This confirms it's a reagent or material used in an in vitro diagnostic test.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Quality control materials like this are essential components of IVD testing to ensure the accuracy and reliability of the results.
N/A
Intended Use / Indications for Use
CANTROL Iron /TIBC Controls provide a simple, but effective, method for the performance of intra- or inter- laboratory quality control in the quantitation of Serum Iron and Total Iron Binding Capacity.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
CANTROL Iron/TIBC Controls are manufactured from human serum and provide a means for monitoring Serum Iron and TIBC testing procedures by the use of control materials in a manner identical to patient samples. CANTROL Iron/TIBC Control materials are equivalent to other human serum based chemistry control products.
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)
Testing of CANTROL Iron/TIBC Control material was accomplished to demonstrate short term and long term product stability. Short term stability was demonstrated by real time product storage. Long term stability was conducted by an accelerated testing protocol as described in the submission data.
Product precision performance was demonstrated through replicate analyses in the conductance during stability testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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
DEC 1 3 1996
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food And Drug Administration 9200 Corporate Boulevard Rockville, MD 20850
510(k) Submission Summary
REJECTED
15 MAR 19 59
FOIA/CDRA/ODE/DI
This summary regarding the enclosed 510(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 Iron /TIBC Controls provide a simple, but effective, method for the performance of intra- or inter- laboratory quality control in the quantitation of Serum Iron and Total Iron Binding Capacity.
CANTROL Iron/TIBC Controls are manufactured from human serum and provide a means for monitoring Serum Iron and TIBC testing procedures by the use of control materials in a manner identical to patient samples. CANTROL Iron/TIBC Control materials are equivalent to other human serum based chemistry control products.
Testing of CANTROL Iron/TIBC Control material was accomplished to demonstrate short term and long term product stability. Short term stability was demonstrated by real time product storage. Long term stability was conducted by an accelerated testing protocol as described in the submission data.
Product precision performance was demonstrated through replicate analyses in the conductance during stability testing.
Submitted by:
Anthony P. Tadkouski
Date:
11-15-96
Anthony Falkowski Owner Canyon Diagnostics 4075 Leaverton Court Anaheim, CA 92807 (714) 632-8711