Cleared Special

K983617 - 25-HYDROXYVITAMIN D 125I RIA KIT

K983617 is an FDA 510(k) clearance for 25-HYDROXYVITAMIN D 125I RIA KIT, manufactured by DiaSorin, Inc.. The device is a Class 1 Chemistry device with product code LCI cleared through the Special 510(k) pathway after a 32-day FDA review.

K983617 · DiaSorin, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
32d
Days
Class 1
Risk

K983617 is an FDA 510(k) clearance for the 25-HYDROXYVITAMIN D 125I RIA KIT. Classified as Automated Radioimmunoassay Systems, For Clinical Use (product code LCI), Class I - General Controls.

Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on November 16, 1998 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K983617

510(k) Number K983617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date November 16, 1998
Days to Decision 32 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 89d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

LCI Device Classification - Class 1, General Controls

Product Code LCI Automated Radioimmunoassay Systems, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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.

K983617 · 25-HYDROXYVITAMIN D 125I RIA KIT
Download PDF FDA Summary DiaSorin, Inc.