Cleared Traditional

K951968 - HUMAN C1Q RADIAL IMMUNODIFFUSION KIT

K951968 is an FDA 510(k) clearance for HUMAN C1Q RADIAL IMMUNODIFFUSION KIT, manufactured by Kent Laboratories, Inc.. The device is a Class 2 Immunology device with product code DAK cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K951968 · Kent Laboratories, Inc. · Immunology device
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May 1995
Decision
33d
Days
Class 2
Risk

K951968 is an FDA 510(k) clearance for the HUMAN C1Q RADIAL IMMUNODIFFUSION KIT. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 33 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 Kent Laboratories, Inc. devices

FDA 510(k) Submission Details - K951968

510(k) Number K951968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1995
Decision Date May 30, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 105d · This submission: 33d
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 16
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K951968.
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
C1 RID KIT
K914388 · The Binding Site, Ltd. · Oct 1991
IC MICROASSAY
K864312 · Diamedix Corp. · Jan 1987
CORDIA IC
K844294 · Cordis Corp. · Feb 1985