Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1410](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1410) → JIY — Photometric Method, Iron (Non-Heme) # JIY · Photometric Method, Iron (Non-Heme) _Clinical Chemistry · 21 CFR 862.1410 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY ## Overview - **Product Code:** JIY - **Device Name:** Photometric Method, Iron (Non-Heme) - **Regulation:** [21 CFR 862.1410](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1410) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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. ## Classification Rationale 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. ## Recent Cleared Devices (20 of 67) Showing 20 most recent of 67 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K061793](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K061793.md) | DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | Aug 7, 2006 | SESE | | [K060264](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K060264.md) | DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) | Dade Behring, Inc. | Mar 8, 2006 | SESE | | [K051115](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K051115.md) | SENTINEL IRON LIQUID | Sentinel Ch. Srl | Aug 25, 2005 | SESE | | [K033983](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K033983.md) | VITALAB IRON REAGENT | Clinical Data, Inc. | May 21, 2004 | SESE | | [K030528](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K030528.md) | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) | Clinical Data | Jun 17, 2003 | SESE | | [K020816](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K020816.md) | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | Diagnostic Chemicals , Ltd. | May 14, 2002 | SESE | | [K013097](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K013097.md) | WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 | Wiener Laboratories Saic | Nov 13, 2001 | SESE | | [K981241](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K981241.md) | IRON | Abbott Laboratories | May 1, 1998 | SESE | | [K973933](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K973933.md) | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 | Diagnostic Chemicals , Ltd. | Nov 4, 1997 | SESE | | [K972363](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K972363.md) | IL TEST IRON | Instrumentation Laboratory CO | Aug 15, 1997 | SESE | | [K964913](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K964913.md) | IRON REAGENT | Derma Media Lab., Inc. | Feb 20, 1997 | SESE | | [K961588](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K961588.md) | TOTAL IRON (NITRO-PAPS) REAGENT SET | Pointe Scientific, Inc., | Nov 18, 1996 | SESE | | [K935712](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K935712.md) | IRON/TIBC REAGENT | Horizon Diagnostics, Inc. | Sep 20, 1995 | SESE | | [K944911](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K944911.md) | ACE IRON REAGENT | Schiapparelli Biosystems, Inc. | Feb 10, 1995 | SESE | | [K943029](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K943029.md) | IRON QVET | Prisma Systems | Dec 2, 1994 | SESE | | [K944462](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K944462.md) | DMA IRON PROCEDURE | Data Medical Associates, Inc. | Nov 15, 1994 | SESE | | [K935287](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K935287.md) | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | Miles, Inc. | Jan 3, 1994 | SESE | | [K935176](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K935176.md) | IRON TEST | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE | | [K930166](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K930166.md) | IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R | Em Diagnostic Systems, Inc. | Apr 21, 1993 | SESE | | [K924691](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY/K924691.md) | OLYMPUS IRON REAGENT | Olympus Corp. | Dec 18, 1992 | SESE | ## Top Applicants - Em Diagnostic Systems, Inc. — 7 clearances - Data Medical Associates, Inc. — 5 clearances - American Dade — 2 clearances - American Monitor Corp. — 2 clearances - Catachem, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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