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 862.1415](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1415) → JMO — Ferrozine (Colorimetric) Iron Binding Capacity # JMO · Ferrozine (Colorimetric) Iron Binding Capacity _Clinical Chemistry · 21 CFR 862.1415 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO ## Overview - **Product Code:** JMO - **Device Name:** Ferrozine (Colorimetric) Iron Binding Capacity - **Regulation:** [21 CFR 862.1415](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1415) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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. ## 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 46) Showing 20 most recent of 46 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K113438](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K113438.md) | ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 1, 2012 | SESE | | [K061464](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K061464.md) | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 | Ortho-Clinical Diagnostics, Inc. | Jun 15, 2006 | SESE | | [K052867](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K052867.md) | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | Ortho-Clinical Diagnostics, Inc. | Dec 23, 2005 | SESE | | [K041793](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K041793.md) | OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 | Olympus America, Inc. | Jul 16, 2004 | SESE | | [K013102](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K013102.md) | WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 | Wiener Laboratories Saic | Nov 13, 2001 | SESE | | [K012340](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K012340.md) | BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) | Bayer Corp. | Oct 1, 2001 | SESE | | [K000781](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K000781.md) | DIRECT TIBC KIT | Reference Diagnostics, Inc. | May 2, 2000 | SESE | | [K994115](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K994115.md) | TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Jan 28, 2000 | SESE | | [K991666](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K991666.md) | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 | A.P. Total Care, Inc. | Jun 30, 1999 | SESE | | [K991244](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K991244.md) | TOTAL IRON, MODELS FE 109-01, FE 109-02 | A.P. Total Care, Inc. | May 25, 1999 | SESE | | [K990216](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K990216.md) | MAGNETIC TIBC KIT | Reference Diagnostics, Inc. | Feb 16, 1999 | SESE | | [K982041](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K982041.md) | UIBC | Abbott Laboratories | Jul 30, 1998 | SESE | | [K981654](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K981654.md) | TIBC | Abbott Laboratories | Jul 22, 1998 | SESE | | [K981279](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K981279.md) | TIBC | Abbott Laboratories | May 20, 1998 | SESE | | [K974604](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K974604.md) | RANDOX IRON | Randox Laboratories, Ltd. | Jan 6, 1998 | SESE | | [K961587](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K961587.md) | IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 | Diagnostic Chemicals , Ltd. | Aug 27, 1996 | SESE | | [K963116](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K963116.md) | UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY | Diagnostic Chemicals , Ltd. | Aug 20, 1996 | SESE | | [K960485](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K960485.md) | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS | Beckman Instruments, Inc. | May 10, 1996 | SESE | | [K955139](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K955139.md) | OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT | Olympus America, Inc. | Feb 12, 1996 | SESE | | [K946354](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO/K946354.md) | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | May 8, 1995 | SESE | ## Top Applicants - Abbott Laboratories — 4 clearances - Em Diagnostic Systems, Inc. — 3 clearances - J.S. Medical Assoc. — 3 clearances - A.P. Total Care, Inc. — 2 clearances - American Research Products Co. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMO) **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