Cleared Traditional

K872227 - LIQUICHEK PEDIATRIC CONTROL LEVELS I AN...

K872227 is the FDA 510(k) clearance for LIQUICHEK PEDIATRIC CONTROL LEVELS I AN... by Bio-Rad. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K872227 · Bio-Rad · Chemistry device
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Jul 1987
Decision
27d
Days
Class 1
Risk

K872227 is an FDA 510(k) clearance for the LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on July 6, 1987 after a review of 27 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 Bio-Rad devices

Submission Details

510(k) Number K872227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1987
Decision Date July 06, 1987
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 467
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K872227.
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · Biotrol, USA, Inc. · Aug 1987
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DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR
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K871342 · Kallestad Diag, A Div. of Erbamont, Inc. · May 1987
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DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET
K870252 · Casco Standards · Feb 1987