Cleared Traditional

K872196 - AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I

K872196 is the FDA 510(k) clearance for AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I by American Dade. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K872196 · American Dade · Chemistry device
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Jul 1987
Decision
53d
Days
Class 1
Risk

K872196 is an FDA 510(k) clearance for the AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 31, 1987 after a review of 53 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 American Dade devices

Submission Details

510(k) Number K872196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date July 31, 1987
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 43
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K872196.
QUALICHECK 3
K904733 · Radiometer America, Inc. · Nov 1990
QUALICHECK 2
K894110 · Radiometer America, Inc. · Aug 1989
MULTI-FUNCTION BLOOD GAS CONTROL
K874408 · Bionostics, Inc. · Dec 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · Ciba Corning Diagnostics Corp. · Jan 1987
MULTI FUNCTION BLOOD GAS CONTROL
K851911 · Bionostics, Inc. · May 1985
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
K841783 · Bionostics, Inc. · Jun 1984