Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3320](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3320) → MIZ — Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

# MIZ · Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

_Microbiology · 21 CFR 866.3320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIZ

## Overview

- **Product Code:** MIZ
- **Device Name:** Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
- **Regulation:** [21 CFR 866.3320](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3320)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Histoplasma capsulatum serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Histoplasma capsulatum in serum. Additionally, some of these reagents consist of Histoplasma capsulatum antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Histoplasma capsulatum from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of histoplasmosis caused by this fungus belonging to the genus Histoplasma and provides epidemiological information on the diseases caused by this fungus. Histoplasmosis usually is a mild and often asymptomatic respiratory infection, but in a small number of infected individuals the lesions may spread to practically all tissues and organs.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K101407](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIZ/K101407.md) | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | Immuno-Mycologics, Inc. | Jul 19, 2011 | SESE |
| [K915700](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIZ/K915700.md) | PERMIER HISTOPLASMA | Meridian Diagnostics, Inc. | Jul 30, 1992 | SESE |

## Top Applicants

- Immuno-Mycologics, Inc. — 1 clearance
- Meridian Diagnostics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIZ](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MIZ)

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