Cleared Traditional

K992939 - QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3

K992939 is an FDA 510(k) clearance for QUALITROL IMMUNOASSAY PLUS CONTROL, manufactured by Seracare Technology. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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

FDA 510(k) Submission Details - K992939

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 105d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

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 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K992939.
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