Cleared Traditional

K862649 - CYTOTECH CIC ENZYME IMMUNOASSAY

K862649 is the FDA 510(k) clearance for CYTOTECH CIC ENZYME IMMUNOASSAY by Cytotech, Inc.. It is a Class 2 Immunology device (product code DAK) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K862649 · Cytotech, Inc. · Immunology device
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Sep 1986
Decision
55d
Days
Class 2
Risk

K862649 is an FDA 510(k) clearance for the CYTOTECH CIC ENZYME IMMUNOASSAY. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on September 4, 1986 after a review of 55 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 Cytotech, Inc. devices

Submission Details

510(k) Number K862649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1986
Decision Date September 04, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 104d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K862649.
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968 · Kent Laboratories, Inc. · May 1995
C1 RID KIT
K914388 · The Binding Site, Ltd. · Oct 1991
IC MICROASSAY
K864312 · Diamedix Corp. · Jan 1987
CORDIA IC
K844294 · Cordis Corp. · Feb 1985
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · Ortho Diagnostic Systems, Inc. · Jun 1984
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949 · Ortho Diagnostic Systems, Inc. · Aug 1982