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) → JQE — Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity

# JQE · Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, 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/JQE

## Overview

- **Product Code:** JQE
- **Device Name:** Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K970248](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE/K970248.md) | CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM | Canyon Diagnostics, Inc. | Feb 11, 1997 | SESE |
| [K934358](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE/K934358.md) | KODAK EKTACHEM DT SLIDES (FE) | Eastman Kodak Company | Mar 21, 1994 | SESE |
| [K910672](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE/K910672.md) | J&S PEDIATRIC IRON SATURATING REAGENT | J.S. Medical Assoc. | Apr 29, 1991 | SESE |
| [K884649](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE/K884649.md) | TOTAL IRON BINDING CAPACITY TEST | Sclavo, Inc. | Dec 14, 1988 | SESE |
| [K864548](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE/K864548.md) | ALFERR TIBC TUBE | Benchmark Reagents | Feb 2, 1987 | SESE |
| [K842019](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE/K842019.md) | TIBC PRETREATMENT KIT | E.I. Dupont DE Nemours & Co., Inc. | Jun 22, 1984 | SESE |

## Top Applicants

- Benchmark Reagents — 1 clearance
- Canyon Diagnostics, Inc. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Eastman Kodak Company — 1 clearance
- J.S. Medical Assoc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQE)

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