Cleared Traditional

K910617 - NATIVE PROTHROMBIN ANTIGEN EIA

K910617 is an FDA 510(k) clearance for NATIVE PROTHROMBIN ANTIGEN EIA, manufactured by Organon Teknika Corp.. The device is a Class 1 Immunology device with product code DDF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K910617 · Organon Teknika Corp. · Immunology device
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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

FDA 510(k) Submission Details - K910617

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 104d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

DDF Device Classification - Class 1, General Controls

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.