Cleared Traditional

K853931 - QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL

K853931 is the FDA 510(k) clearance for QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL by Quantimetrix Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K853931 · Quantimetrix Corp. · Chemistry device
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Oct 1985
Decision
10d
Days
Class 1
Risk

K853931 is an FDA 510(k) clearance for the QUANTIMETRIX HUMAN SERUM CHEMISTRY 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 October 4, 1985 after a review of 10 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K853931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date October 04, 1985
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
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 K853931.
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED
K861000 · Ciba Corning Diagnostics Corp. · Apr 1986
BOVINE CHEMISTRY CONTROL I.X AND II.X
K860355 · American Dade · Mar 1986
RANGE-CHEK
K854789 · American Monitor Corp. · Jan 1986
DC LIQUITROL LEVEL 1 & 2
K852753 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1985
DC-LIP, CATALOGUE NUMBER SE-020
K852594 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
K851942 · Coulter Electronics, Inc. · May 1985