Cleared Traditional

K792098 - GAS-TRAK BLOOD GAS CONTROL

K792098 is an FDA 510(k) clearance for GAS-TRAK BLOOD GAS CONTROL, manufactured by United Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K792098 · United Diagnostics, Inc. · Chemistry device
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Nov 1979
Decision
25d
Days
Class 1
Risk

K792098 is an FDA 510(k) clearance for the GAS-TRAK BLOOD GAS CONTROL. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by United Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 25 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 United Diagnostics, Inc. devices

FDA 510(k) Submission Details - K792098

510(k) Number K792098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1979
Decision Date November 13, 1979
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

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 59
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K792098.
AQUEOUS BLOOD GAS CONTROLS
K812553 · Fisher Scientific Co., LLC · Sep 1981
PH/BLOOD GAS CONTROL (ABC)
K811143 · Instrumentation Laboratory CO · May 1981
REFEREE BFT BLOOD FOR TONOMETRY
K792447 · Analytical Products, Inc. · Dec 1979
FISHER DIAG. PRIME BLOOD GAS CONTROLS
K792143 · Fisher Scientific Co., LLC · Nov 1979
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180 · Corning Medical & Scientific · Nov 1979
MULTECON BLOOD GAS CONTROL
K790813 · Ortho Diagnostics, Inc. · Jun 1979