Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5590](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5590) → DEL — Lipoprotein X, Antigen, Antiserum, Control

# DEL · Lipoprotein X, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5590 · Class 1_

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

## Overview

- **Product Code:** DEL
- **Device Name:** Lipoprotein X, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5590](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5590)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.

## 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K013278](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEL/K013278.md) | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | Roche Diagnostics Corp. | Nov 15, 2001 | SESE |
| [K901675](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEL/K901675.md) | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | Apr 26, 1990 | SESE |
| [K900124](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEL/K900124.md) | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | Mar 2, 1990 | SESE |
| [K895160](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEL/K895160.md) | ORTHO *APO A-1 ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | Oct 6, 1989 | SESE |
| [K893885](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEL/K893885.md) | BACTON TM, BASIC TM, APO A-I REAGENT | Catachem, Inc. | Jun 21, 1989 | SESE |

## Top Applicants

- Sigma Chemical Co. — 2 clearances
- Roche Diagnostics Corp. — 1 clearance
- Medical Marketing Consultants, Inc. — 1 clearance
- Catachem, Inc. — 1 clearance

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

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