LKL · Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5420 · Class 1
Overview
| Product Code | LKL |
|---|---|
| Device Name | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5420 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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 | K-ASSAY ALPHA-1 AG | Kamiya Biomedical Co. | Nov 24, 1999 | SESE |
| K964299 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE |
| K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | Beckman Instruments, Inc. | Mar 24, 1997 | SESE |
| K922417 | AL-ACID GLYCOPROTEIN RID KIT | The Binding Site, Ltd. | Aug 20, 1992 | SESE |
| K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Reagents Applications, Inc. | Nov 13, 1990 | SESE |
| K884217 | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | Technicon Instruments Corp. | Nov 4, 1988 | SESE |
| K873868 | ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) | Unipath , Ltd. | Oct 20, 1987 | SESE |
| K862087 | SANTEST 1AP | Scientific Sales Intl., Inc. | Dec 3, 1986 | SESE |
| K861336 | IAP PLATE TEST | Scientific Sales Intl., Inc. | Apr 25, 1986 | SESE |
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Tago, Inc. | Jun 1, 1984 | SESE |
| K831960 | TEST FOR HUMAN ALPHA ONE ACID GLYCO- | Kent Laboratories, Inc. | Jul 19, 1983 | SESE |
Top Applicants
- Scientific Sales Intl., Inc. — 2 clearances
- Unipath , Ltd. — 1 clearance
- The Binding Site, Ltd. — 1 clearance
- Technicon Instruments Corp. — 1 clearance
- Tago, Inc. — 1 clearance
