Cleared Traditional

QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (K992939) - FDA 510(k) Clearance

Class I Immunology device.

K992939 · Seracare Technology · Immunology device
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Dec 1999
Decision
100d
Days
Class 1
Risk

K992939 is an FDA 510(k) clearance for the QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3. 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 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Seracare Technology devices

Submission Details

510(k) Number K992939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1999
Decision Date December 09, 1999
Days to Decision 100 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
4d faster than avg
Panel avg: 104d · This submission: 100d
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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