Cleared Traditional

K984186 - NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY

K984186 is an FDA 510(k) clearance for NICHOLS ADVANTAGE CHEMILUMINESCENCE FER..., manufactured by Nichols Institute Diagnostics. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K984186 · Nichols Institute Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
71d
Days
Class 2
Risk

K984186 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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 Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K984186

510(k) Number K984186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date February 02, 1999
Days to Decision 71 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
34d faster than avg
Panel avg: 105d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - DBF Ferritin, Antigen, Antiserum, Control

All 75
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K984186.
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ABBOTT ARCHITECT FERRITIN
K983759 · Abbott Laboratories · Dec 1998
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K982714 · Bayer Corp. · Oct 1998