JZJ · Prealbumin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5060 · Class 1
Overview
| Product Code | JZJ |
|---|---|
| Device Name | Prealbumin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5060 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
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 |
|---|---|---|---|---|
| K000661 | RANDOX PREALBUMIN | Randox Laboratories, Ltd. | Apr 13, 2000 | SESE |
| K972638 | TINA-QUANT PREALBUMIN | Boehringer Mannheim Corp. | Jan 9, 1998 | SESE |
| K951966 | HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | Jun 1, 1995 | SESE |
| K913672 | PREALBUMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | Dec 20, 1991 | SESE |
| K884298 | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN | Atlantic Antibodies | Nov 2, 1988 | SESE |
| K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN | Atlantic Antibodies | Nov 2, 1988 | SESE |
| K883002 | QM300 PREALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Sep 22, 1988 | SESE |
| K850686 | ANTISERUM TO HUMAN PREALBUMIN | Kent Laboratories, Inc. | Nov 1, 1985 | SESE |
| K851912 | LASER PREALBUMIN TEST | Behring Diagnostics, Inc. | Jun 21, 1985 | SESE |
| K821135 | PREALBUMIN ENZYME IMMUNOASSAY | Abbott Laboratories | May 5, 1983 | SESE |
| K772329 | LAS-R HUMAN PREALBUMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | Feb 3, 1978 | SESE |
Top Applicants
- Kent Laboratories, Inc. — 2 clearances
- Atlantic Antibodies — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- Randox Laboratories, Ltd. — 1 clearance
- Kallestad Diag, A Div. of Erbamont, Inc. — 1 clearance
