Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5735](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5735) → DDF — Prothrombin, Antigen, Antiserum, Control

# DDF · Prothrombin, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5735 · Class 1_

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

## Overview

- **Product Code:** DDF
- **Device Name:** Prothrombin, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5735](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5735)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.

## 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. This exemption does not apply to multipurpose systems for in vitro coagulation studies classified under § 864.5425 of this chapter or prothrombin time tests classified under § 864.7750 of this chapter.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K910617](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF/K910617.md) | NATIVE PROTHROMBIN ANTIGEN EIA | Organon Teknika Corp. | May 15, 1991 | SESE |
| [K812985](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF/K812985.md) | AGGLUTEX MORPHINE TEST KIT | Hoffmann-La Roche, Inc. | Dec 31, 1981 | SESE |

## Top Applicants

- Organon Teknika Corp. — 1 clearance
- Hoffmann-La Roche, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com