Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5110](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5110) → MLE — Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

# MLE · Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control

_Immunology · 21 CFR 866.5110 · Class 2_

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

## Overview

- **Product Code:** MLE
- **Device Name:** Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- **Regulation:** [21 CFR 866.5110](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5110)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12 to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12 deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K010558](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MLE/K010558.md) | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | Inova Diagnostics, Inc. | Apr 3, 2001 | SESE |
| [K991942](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MLE/K991942.md) | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | Cogent Diagnotics , Ltd. | Aug 24, 1999 | SESE |
| [K951206](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MLE/K951206.md) | VARELISA PARIETAL CELL ANTIBODIES | Elias U.S.A., Inc. | Apr 17, 1995 | SESE |

## Top Applicants

- Cogent Diagnotics , Ltd. — 1 clearance
- Elias U.S.A., Inc. — 1 clearance
- Inova Diagnostics, Inc. — 1 clearance

---

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

**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