Cleared Traditional

K780144 - DYNEX BLOOD GAS QUALITY CONTROL SYS.

K780144 is an FDA 510(k) clearance for DYNEX BLOOD GAS QUALITY CONTROL SYS., manufactured by Analytical Products, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K780144 · Analytical Products, Inc. · Chemistry device
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May 1978
Decision
122d
Days
Class 1
Risk

K780144 is an FDA 510(k) clearance for the DYNEX BLOOD GAS QUALITY CONTROL SYS.. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Analytical Products, Inc. devices

FDA 510(k) Submission Details - K780144

510(k) Number K780144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1978
Decision Date May 26, 1978
Days to Decision 122 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
34d slower than avg
Panel avg: 88d · This submission: 122d
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 57
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K780144.
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
WHOLE BLOOD GAS CONTROL
K770950 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1977
TMA BICARBONATE DILUENT
K771044 · Hyland Therapeutic Div., Travenol Laboratories · Jul 1977
AQUEOUS PH/BLOOD GAS CONTROLS
K770228 · Instrumentation Laboratory CO · Jun 1977