Cleared Traditional

QUALICHECK 2 (K894110) - FDA 510(k) Clearance

Class I Chemistry device.

K894110 · Radiometer America, Inc. · Chemistry device
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Aug 1989
Decision
52d
Days
Class 1
Risk

K894110 is an FDA 510(k) clearance for the QUALICHECK 2. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 52 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 Radiometer America, Inc. devices

Submission Details

510(k) Number K894110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1989
Decision Date August 03, 1989
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
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 - JJS Controls For Blood-gases, (assayed And Unassayed)

All 22
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K894110.
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · Bio-Rad · Aug 2000
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861 · Instrumentation Laboratory CO · Aug 1997
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · Ciba Corning Diagnostics Corp. · Jan 1995
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196 · American Dade · Jul 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · Ciba Corning Diagnostics Corp. · Jan 1987
AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
K832003 · American Dade · Aug 1983