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) → JJA — Radio-Labeled Iron Method, Iron (Non-Heme)

# JJA · Radio-Labeled Iron 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/JJA

## Overview

- **Product Code:** JJA
- **Device Name:** Radio-Labeled Iron 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K820253](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJA/K820253.md) | SIMUL-FER SERUM IRON TEST KIT | Diagnostic Reagents, Inc. | May 12, 1982 | SESE |
| [K782159](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJA/K782159.md) | DIAGNOSTIC KIT, FERRITAB-FE-59 | Leeco Diagnostics, Inc. | Feb 1, 1979 | SESE |
| [K781769](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJA/K781769.md) | IRON 59 KIT | Ria Products, Inc. | Dec 4, 1978 | SESE |
| [K760045](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJA/K760045.md) | KIT, RADIOASSAY, SERUM IRON | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 20, 1976 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Diagnostic Reagents, Inc. — 1 clearance
- Leeco Diagnostics, Inc. — 1 clearance
- Ria Products, Inc. — 1 clearance

---

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

**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