Cleared Traditional

K830181 - REFEREE BLOOD GAS ANALYZER CONTROLS

K830181 is the FDA 510(k) clearance for REFEREE BLOOD GAS ANALYZER CONTROLS by Analytical Products, Inc.. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K830181 · Analytical Products, Inc. · Chemistry device
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Feb 1983
Decision
41d
Days
Class 1
Risk

K830181 is an FDA 510(k) clearance for the REFEREE BLOOD GAS ANALYZER CONTROLS. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Analytical Products, Inc. (Belmont, US). The FDA issued a Cleared decision on February 28, 1983 after a review of 41 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 Analytical Products, Inc. devices

Submission Details

510(k) Number K830181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1983
Decision Date February 28, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 25
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K830181.
BAYER HEALTHCARE RAPIDQC PLUS
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AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
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CERTAIN HB CO-OXIMETER CONTROL
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CORNING CERTAIN TM
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FETAL-TEK CONTROL MATURE
K820319 · Helena Laboratories · Mar 1982
PATHWAY PH BLOOD GAS CONTROL
K820103 · Beckman Instruments, Inc. · Jan 1982