Cleared Traditional

K884217 - TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (FDA 510(k) Clearance)

Class I Immunology device.

K884217 · Technicon Instruments Corp. · Immunology device
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Nov 1988
Decision
23d
Days
Class 1
Risk

K884217 is an FDA 510(k) clearance for the TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN. Classified as Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (product code LKL), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 4, 1988 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5420 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K884217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date November 04, 1988
Days to Decision 23 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 104d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.