Cleared Traditional

K843225 - COLORZYME NDNA TEST SYSTEM

K843225 is the FDA 510(k) clearance for COLORZYME NDNA TEST SYSTEM by Immuno Concepts, Inc.. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K843225 · Immuno Concepts, Inc. · Immunology device
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Nov 1984
Decision
77d
Days
Class 2
Risk

K843225 is an FDA 510(k) clearance for the COLORZYME NDNA TEST SYSTEM. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on November 1, 1984 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Immuno Concepts, Inc. devices

Submission Details

510(k) Number K843225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1984
Decision Date November 01, 1984
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 104d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 51
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K843225.
ANTI-DNP MICROASSAY
K872560 · Diamedix Corp. · Jul 1987
ANTI-DNA MICROASSAY
K863717 · Diamedix Corp. · Oct 1986
AFT-HEP SYSTEM
K860183 · Behring Diagnostics, Inc. · Feb 1986
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · Behring Diagnostics, Inc. · Jun 1984
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127 · Electro-Nucleonics Laboratories, Inc. · Apr 1984