Cleared Traditional

K961912 - QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET

K961912 is an FDA 510(k) clearance for QUALITROL, manufactured by Consolidated Technologies, Inc.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K961912

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 105d · This submission: 90d
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 K961912.
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NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
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DOCUMENT CARDIAC ASSAYED CONTROL
K961750 · Casco Standards · Jul 1996
ELECSYS PRECICONTROL CARDIAC
K962575 · Boehringer Mannheim Corp. · Jul 1996