Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5660](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5660) → NBS — Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

# NBS · Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

_Immunology · 21 CFR 866.5660 · Class 2_

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

## Overview

- **Product Code:** NBS
- **Device Name:** Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
- **Regulation:** [21 CFR 866.5660](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5660)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K163538](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NBS/K163538.md) | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Inova Diagnostics, Inc. | Sep 6, 2017 | SESE |
| [K112223](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NBS/K112223.md) | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | Euroimmun US | Sep 11, 2012 | SESE |
| [K000535](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NBS/K000535.md) | QUANTA LITE LKM-1 ELISA | Inova Diagnostics, Inc. | Jun 7, 2000 | SESE |

## Top Applicants

- Inova Diagnostics, Inc. — 2 clearances
- Euroimmun US — 1 clearance

---

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

**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