Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5120](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5120) → DBE — Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

# DBE · Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control

_Immunology · 21 CFR 866.5120 · Class 2_

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

## Overview

- **Product Code:** DBE
- **Device Name:** Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- **Regulation:** [21 CFR 866.5120](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5120)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K810983](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K810983.md) | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | Immuno-Products Industries | May 1, 1981 | SESE |
| [K800820](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K800820.md) | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | Calbiochem-Behring Corp. | Apr 24, 1980 | SESE |
| [K800228](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K800228.md) | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | Clinical Sciences, Inc. | Feb 21, 1980 | SESE |
| [K790430](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K790430.md) | MEDICA II-F-ASMA TEST KIT | Medica Corp. | Apr 23, 1979 | SESE |
| [K771155](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K771155.md) | ANTI-MITOCHONDRIAL | Meloy Laboratories, Inc. | Aug 4, 1977 | SESE |
| [K760156](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K760156.md) | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | Zeus Scientific, Inc. | Jul 20, 1976 | SESE |

## Top Applicants

- Zeus Scientific, Inc. — 1 clearance
- Meloy Laboratories, Inc. — 1 clearance
- Medica Corp. — 1 clearance
- Immuno-Products Industries — 1 clearance
- Clinical Sciences, Inc. — 1 clearance

---

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

**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