Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5060](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5060) → DDS — Prealbumin, Fitc, Antigen, Antiserum, Control

# DDS · Prealbumin, Fitc, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5060 · Class 1_

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

## Overview

- **Product Code:** DDS
- **Device Name:** Prealbumin, Fitc, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5060](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5060)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K972812](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K972812.md) | RAICHEM PREALBUMIN SPIA | Hemagen Diagnostics, Inc. | Aug 28, 1997 | SESE |
| [K964781](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K964781.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | Beckman Instruments, Inc. | May 9, 1997 | SESE |
| [K934966](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K934966.md) | SPQ PAL CONTROL LEVEL II | Incstar Corp. | Jan 11, 1994 | SESE |
| [K854811](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDS/K854811.md) | ICS PAB PREALBUMIN REAGENT TEST KIT | Beckman Instruments, Inc. | Jan 24, 1986 | SESE |

## Top Applicants

- Beckman Instruments, Inc. — 2 clearances
- Hemagen Diagnostics, Inc. — 1 clearance
- Incstar Corp. — 1 clearance

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

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