Cleared Traditional

K032254 - IBL C1Q-CIC CIA TEST

K032254 is an FDA 510(k) clearance for IBL C1Q-CIC CIA TEST, manufactured by Ibl GmbH. The device is a Class 2 Immunology device with product code DAK cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K032254 · Ibl GmbH · Immunology device
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Aug 2003
Decision
38d
Days
Class 2
Risk

K032254 is an FDA 510(k) clearance for the IBL C1Q-CIC CIA TEST. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ibl GmbH devices

FDA 510(k) Submission Details - K032254

510(k) Number K032254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2003
Decision Date August 29, 2003
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 105d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAK Device Classification - Class 2, Special Controls

Product Code DAK Complement C1q, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DAK Complement C1q, Antigen, Antiserum, Control

All 17
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K032254.
BINDAZYME CLQ CIC EIA KIT
K031563 · The Binding Site, Ltd. · Sep 2003
CIC-C1Q EIA
K012576 · American Laboratory Products Co., Ltd. · Jan 2002
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
K973203 · Sangstat Medical Corp. · Sep 1998
IMMUSTRIP HAMA IGG
K972873 · Immunomedics, Inc. · Mar 1998
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968 · Kent Laboratories, Inc. · May 1995
C1 RID KIT
K914388 · The Binding Site, Ltd. · Oct 1991