Cleared Traditional

K946266 - FERRITIN CONTROL - LEVEL 1, 2, 3

K946266 is an FDA 510(k) clearance for FERRITIN CONTROL - LEVEL 1, manufactured by Clinical Controls, Inc.. The device is a Class 2 Immunology device with product code DGD cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K946266 · Clinical Controls, Inc. · Immunology device
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Feb 1995
Decision
49d
Days
Class 2
Risk

K946266 is an FDA 510(k) clearance for the FERRITIN CONTROL - LEVEL 1, 2, 3. Classified as Igg, Ferritin, Antigen, Antiserum, Control (product code DGD), Class II - Special Controls.

Submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Clinical Controls, Inc. devices

FDA 510(k) Submission Details - K946266

510(k) Number K946266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date February 10, 1995
Days to Decision 49 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
56d faster than avg
Panel avg: 105d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGD Device Classification - Class 2, Special Controls

Product Code DGD Igg, Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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.