Cleared Traditional

K780490 - NEIA-FERRITIN ENZYMEIMMUNOASSAY

K780490 is an FDA 510(k) clearance for NEIA-FERRITIN ENZYMEIMMUNOASSAY, manufactured by New England Immunology Assoc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K780490 · New England Immunology Assoc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1978
Decision
14d
Days
Class 2
Risk

K780490 is an FDA 510(k) clearance for the NEIA-FERRITIN ENZYMEIMMUNOASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by New England Immunology Assoc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1978 after a review of 14 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.

FDA 510(k) Submission Details - K780490

510(k) Number K780490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1978
Decision Date April 10, 1978
Days to Decision 14 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
91d faster than avg
Panel avg: 105d · This submission: 14d
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.

K780490 · NEIA-FERRITIN ENZYMEIMMUNOASSAY
Download PDF New England Immunolog…