Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5420](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5420) → LKL — Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

# LKL · Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5420 · Class 1_

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

## Overview

- **Product Code:** LKL
- **Device Name:** Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5420](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5420)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K993441](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K993441.md) | K-ASSAY ALPHA-1 AG | Kamiya Biomedical Co. | Nov 24, 1999 | SESE |
| [K964299](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K964299.md) | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE |
| [K964257](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K964257.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | Beckman Instruments, Inc. | Mar 24, 1997 | SESE |
| [K922417](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K922417.md) | AL-ACID GLYCOPROTEIN RID KIT | The Binding Site, Ltd. | Aug 20, 1992 | SESE |
| [K904175](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K904175.md) | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Reagents Applications, Inc. | Nov 13, 1990 | SESE |
| [K884217](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K884217.md) | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | Technicon Instruments Corp. | Nov 4, 1988 | SESE |
| [K873868](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K873868.md) | ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) | Unipath , Ltd. | Oct 20, 1987 | SESE |
| [K862087](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K862087.md) | SANTEST 1AP | Scientific Sales Intl., Inc. | Dec 3, 1986 | SESE |
| [K861336](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K861336.md) | IAP PLATE TEST | Scientific Sales Intl., Inc. | Apr 25, 1986 | SESE |
| [K841734](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K841734.md) | TAGO FIFFU-GEN, OROSOMUCOID | Tago, Inc. | Jun 1, 1984 | SESE |
| [K831960](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LKL/K831960.md) | TEST FOR HUMAN ALPHA ONE ACID GLYCO- | Kent Laboratories, Inc. | Jul 19, 1983 | SESE |

## Top Applicants

- Scientific Sales Intl., Inc. — 2 clearances
- Beckman Instruments, Inc. — 1 clearance
- Crestat Diagnostics, Inc. — 1 clearance
- Kamiya Biomedical Co. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance

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

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