Cleared Traditional

K861420 - QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL

K861420 is the FDA 510(k) clearance for QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL by Quantimetrix Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K861420 · Quantimetrix Corp. · Chemistry device
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Sep 1986
Decision
154d
Days
Class 1
Risk

K861420 is an FDA 510(k) clearance for the QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on September 16, 1986 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K861420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date September 16, 1986
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 88d · This submission: 154d
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 318
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K861420.
SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)
K871058 · Fisher Scientific Co., LLC · Apr 1987
MULTI-ANALYTE LIN-TROL
K863751 · Sigma Diagnostics, Inc. · Nov 1986
ABNORMAL SPINAL FLUID CONTROL
K863745 · Ciba Corning Diagnostics Corp. · Oct 1986
THERAPEUTIC DRUG MONITORING CONTROL SET
K862963 · American Monitor Corp. · Sep 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · Bio-Rad · Aug 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · Ciba Corning Diagnostics Corp. · Jul 1986