Cleared Special

K982637 - IMMULITE PSA CONTROL MODULE, MODEL LPSCM

K982637 is an FDA 510(k) clearance for IMMULITE PSA CONTROL MODULE, manufactured by Diagnostic Products Corp.. The device is a Class 1 Immunology device with product code JJY cleared through the Special 510(k) pathway after a 14-day FDA review.

K982637 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
14d
Days
Class 1
Risk

K982637 is an FDA 510(k) clearance for the IMMULITE PSA CONTROL MODULE, MODEL LPSCM. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 12, 1998 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 - K982637

510(k) Number K982637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1998
Decision Date August 12, 1998
Days to Decision 14 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
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
Modification to existing cleared device.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJY Multi-analyte Controls, All Kinds (assayed)

All 657
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K982637.
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K982637 · IMMULITE PSA CONTROL MODULE, MODEL LPSCM
Download PDF FDA Summary Diagnostic Products C…