Cleared Traditional

K915399 - QUALICHECK 4

K915399 is an FDA 510(k) clearance for QUALICHECK 4, manufactured by Radiometer America, Inc.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K915399 · Radiometer America, Inc. · Chemistry device
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Jan 1992
Decision
34d
Days
Class 1
Risk

K915399 is an FDA 510(k) clearance for the QUALICHECK 4. 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 January 2, 1992 after a review of 34 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

FDA 510(k) Submission Details - K915399

510(k) Number K915399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date January 02, 1992
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K915399.
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K901985 · Phoenix Diagnostics, Inc. · Jun 1990
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K901976 · Phoenix Diagnostics, Inc. · May 1990