Cleared Traditional

K830357 - RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E

K830357 is the FDA 510(k) clearance for RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E by Clinetics Corp.. It is a Class 2 Chemistry device (product code DGC) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K830357 · Clinetics Corp. · Chemistry device
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Mar 1983
Decision
42d
Days
Class 2
Risk

K830357 is an FDA 510(k) clearance for the RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Clinetics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 Clinetics Corp. devices

Submission Details

510(k) Number K830357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1983
Decision Date March 17, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, 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 Chemistry devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 84
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K830357.
VENTRE/ZYME IGE KIT
K831485 · Ventrex Laboratories, Inc. · Jun 1983
IGE-QUANT DIAGNOSTIC TEST KIT
K831208 · Leeco Diagnostics, Inc. · May 1983
NEW ALLERGEN DISCS FOR USE IN VAST VENT
K830817 · Ventrex Laboratories, Inc. · Apr 1983
PHADEBAS RAST ALLERGEN DISCS
K823841 · Pharmacia, Inc. · Jan 1983
PHADEZYM RAST ALLERGEN DISCS
K823842 · Pharmacia, Inc. · Jan 1983
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
K823507 · Hybritech, Inc. · Dec 1982