Cleared Traditional

K840103 - RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN

K840103 is the FDA 510(k) clearance for RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN by Techniclone Intl.. It is a Class 2 Immunology device (product code JHR) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K840103 · Techniclone Intl. · Immunology device
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Feb 1984
Decision
31d
Days
Class 2
Risk

K840103 is an FDA 510(k) clearance for the RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN. Classified as Radioimmunoassay, Immunoglobulins (d, E) (product code JHR), Class II - Special Controls.

Submitted by Techniclone Intl. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 31 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 Techniclone Intl. devices

Submission Details

510(k) Number K840103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date February 10, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 104d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHR Radioimmunoassay, Immunoglobulins (d, E)
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.