← Product Code [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY) · K964640 # CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 (K964640) _Canyon Diagnostics, Inc. · JJY · Dec 13, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K964640 ## Device Facts - **Applicant:** Canyon Diagnostics, Inc. - **Product Code:** [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY.md) - **Decision Date:** Dec 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## 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. ## Device Story CANTROL Iron/TIBC Controls; human serum-based control material; used for intra- or inter-laboratory quality control; monitors performance of Serum Iron and TIBC assays; processed identically to patient samples; provides verification of testing procedure accuracy and precision; used by laboratory personnel in clinical settings. ## Clinical Evidence Bench testing only; stability demonstrated via real-time (short-term) and accelerated (long-term) testing protocols; precision performance validated through replicate analyses. ## Technological Characteristics Human serum-based control material; liquid/reconstituted form; intended for use with standard clinical chemistry analyzers for iron/TIBC quantitation. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} CANYON DIAGNOSTICS, INC. 4075 Leaverton Court • Anaheim, CA 92807 714-632-8711 • FAX 714-632-9407 • 800-445-1146 K964640 DEC 13 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 ![img-0.jpeg](img-0.jpeg) 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 Falkowski Owner Canyon Diagnostics 4075 Leaverton Court Anaheim, CA 92807 (714) 632-8711 Date: 11-15-96 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K964640](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K964640) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com