Cleared Traditional

K960257 - N ANTISERUM TO C1 INHIBITOR

K960257 is an FDA 510(k) clearance for N ANTISERUM TO C1 INHIBITOR, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBA cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K960257 · Behring Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K960257

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 105d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DBA Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control

All 11
Devices cleared under the same product code (DBA) and FDA review panel - the closest regulatory comparables to K960257.
K-ASSAY C1-INA
K011780 · Kamiya Biomedical Co. · Jul 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · Baxter Healthcare Corp · Mar 2001
N-ASSAY TIA C1-INACTIVATOR TEST KIT
K965024 · Crestat Diagnostics, Inc. · Jul 1997
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967 · Kent Laboratories, Inc. · May 1995
COMPLEMENT C1 INACTIVATOR KIT
K915431 · The Binding Site, Ltd. · Jan 1992
ORTHO CLASSICAL PATHWAY COMPL. TEST
K821898 · Ortho Diagnostic Systems, Inc. · Jul 1982