Cleared Traditional

QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET (K961912) - FDA 510(k) Clearance

Class I Immunology device.

K961912 · Consolidated Technologies, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 672
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K961912.
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · Helena Laboratories · Oct 2013
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · Dade Behring, Inc. · Sep 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · Roche Diagnostics Corp. · Mar 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · Roche Diagnostics Corp. · Jan 2007
TDM CONTROL SET
K060429 · Roche Diagnostics Corp. · Mar 2006
ELECSYS PRECICONTROL BONE
K051543 · Roche Diagnostics Corp. · Oct 2005