Cleared Traditional

K910617 - NATIVE PROTHROMBIN ANTIGEN EIA (FDA 510(k) Clearance)

Class I Immunology device.

K910617 · Organon Teknika Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
92d
Days
Class 1
Risk

K910617 is an FDA 510(k) clearance for the NATIVE PROTHROMBIN ANTIGEN EIA. Classified as Prothrombin, Antigen, Antiserum, Control (product code DDF), Class I - General Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5735 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon Teknika Corp. devices

Submission Details

510(k) Number K910617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date May 15, 1991
Days to Decision 92 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 104d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DDF Prothrombin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5735
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.