Cleared Traditional

K993631 - QUALITROL TUMOR MARKER CONTROL

K993631 is the FDA 510(k) clearance for QUALITROL TUMOR MARKER CONTROL by Seracare Technology. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K993631 · Seracare Technology · Immunology device
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Dec 1999
Decision
43d
Days
Class 1
Risk

K993631 is an FDA 510(k) clearance for the QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Seracare Technology (Austin, US). The FDA issued a Cleared decision on December 9, 1999 after a review of 43 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. 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 Seracare Technology devices

Submission Details

510(k) Number K993631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1999
Decision Date December 09, 1999
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 104d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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)

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