Cleared Traditional

K961912 - QUALITROL

K961912 is the FDA 510(k) clearance for QUALITROL by Consolidated Technologies, Inc.. It is a Class 1 Immunology device (product code JJY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961912 · Consolidated Technologies, Inc. · Immunology device
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Aug 1996
Decision
90d
Days
Class 1
Risk

K961912 is an FDA 510(k) clearance for the QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 90 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 Consolidated Technologies, Inc. devices

Submission Details

510(k) Number K961912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date August 15, 1996
Days to Decision 90 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
14d faster than avg
Panel avg: 104d · This submission: 90d
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)

All 464
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K961912.
N/T PROTEIN CONTROL SL
K964065 · Behring Diagnostics, Inc. · Nov 1996
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
K961941 · Bio-Rad · Sep 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982 · Nova Biomedical Corp. · Aug 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
K962997 · Nova Biomedical Corp. · Aug 1996
DOCUMENT CARDIAC ASSAYED CONTROL
K961750 · Casco Standards · Jul 1996
ELECSYS PRECICONTROL CARDIAC
K962575 · Boehringer Mannheim Corp. · Jul 1996