Cleared Traditional

K003747 - C1-INHIBITOR MICROTITER ASSAY DEVICE

K003747 is an FDA 510(k) clearance for C1-INHIBITOR MICROTITER ASSAY DEVICE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Immunology device with product code DBA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K003747 · Baxter Healthcare Corp · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
105d
Days
Class 2
Risk

K003747 is an FDA 510(k) clearance for the C1-INHIBITOR MICROTITER ASSAY DEVICE. Classified as Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (product code DBA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Glendale, US). The FDA issued a Cleared decision on March 19, 2001 after a review of 105 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K003747

510(k) Number K003747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date March 19, 2001
Days to Decision 105 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
At panel average
Panel avg: 105d · This submission: 105d
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 K003747.
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
K122304 · The Binding Site Group , Ltd. · Apr 2013
DIMENSION VISTA C1 IN
K072965 · Dade Behring, Inc. · Dec 2007
K-ASSAY C1-INA
K011780 · Kamiya Biomedical Co. · Jul 2001
N-ASSAY TIA C1-INACTIVATOR TEST KIT
K965024 · Crestat Diagnostics, Inc. · Jul 1997
N ANTISERUM TO C1 INHIBITOR
K960257 · Behring Diagnostics, Inc. · Aug 1996
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967 · Kent Laboratories, Inc. · May 1995