Cleared Traditional

K860942 - QUANTIMETRIX HUMAN BILIRUBIN CONTROL I ...

K860942 is the FDA 510(k) clearance for QUANTIMETRIX HUMAN BILIRUBIN CONTROL I ... by Quantimetrix Corp.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K860942 · Quantimetrix Corp. · Chemistry device
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May 1986
Decision
72d
Days
Class 1
Risk

K860942 is an FDA 510(k) clearance for the QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID. 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 May 23, 1986 after a review of 72 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 K860942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1986
Decision Date May 23, 1986
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
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 K860942.
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · Bio-Rad · Aug 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · Ciba Corning Diagnostics Corp. · Jul 1986
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
K860906 · American Dade · May 1986
THERACHEM-PLUS, TRI-LEVEL TDC (TM)
K861185 · Fisher Scientific Co., LLC · May 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
IRON PROCEDURE
K861603 · Data Medical Associates, Inc. · May 1986