Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5560](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5560) → DET — Lactic Dehydrogenase, Antigen, Antiserum, Control

# DET · Lactic Dehydrogenase, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5560 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET

## Overview

- **Product Code:** DET
- **Device Name:** Lactic Dehydrogenase, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5560](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5560)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A lactic dehydrogenase immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the activity of the lactic dehydrogenase enzyme in serum. Increased levels of lactic dehydrogenase are found in a variety of conditions, including megaloblastic anemia (decrease in the number of mature red blood cells), myocardial infarction (heart disease), and some forms of leukemia (cancer of the blood-forming organs). However, the diagnostic usefulness of this device is limited because of the many conditions known to cause increased lactic dehydrogenase levels.

## 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 § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K900107](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET/K900107.md) | LD-1 | Boehringer Mannheim Corp. | Jan 18, 1990 | SESE |

## Top Applicants

- Boehringer Mannheim Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DET)

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