← Product Code [DDC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC) · K865020

# SERA-TEK THYROGLOBULIN ANTIBODY TEST (K865020)

_Miles Laboratories, Inc. · DDC · Feb 2, 1987 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC/K865020

## Device Facts

- **Applicant:** Miles Laboratories, Inc.
- **Product Code:** [DDC](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC.md)
- **Decision Date:** Feb 2, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5870
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC/K865020](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDC/K865020)

**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