Cleared Traditional

N ANTISERUM TO C1 INHIBITOR (K960257) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960257 · Behring Diagnostics, Inc. · Immunology device
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Aug 1996
Decision
196d
Days
Class 2
Risk

K960257 is an FDA 510(k) clearance for the N ANTISERUM TO C1 INHIBITOR. Classified as Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (product code DBA), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 196 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5250 - 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K960257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1996
Decision Date August 01, 1996
Days to Decision 196 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 104d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBA Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.