Cleared Traditional

K150226 - Hematocrit and Metabolite QUALICHECK

K150226 is an FDA 510(k) clearance for Hematocrit and Metabolite QUALICHECK, manufactured by Radiometer Medical Aps. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K150226 · Radiometer Medical Aps · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
100d
Days
Class 1
Risk

K150226 is an FDA 510(k) clearance for the Hematocrit and Metabolite QUALICHECK. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Radiometer Medical Aps (Bronshoj, DK). The FDA issued a Cleared decision on May 13, 2015 after a review of 100 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 Radiometer Medical Aps devices

FDA 510(k) Submission Details - K150226

510(k) Number K150226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date May 13, 2015
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
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 K150226.
HIGH METABOLITE QUALICHECK
K130415 · Radiometer Medical Aps · Mar 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
K130236 · Radiometer Medical Aps · Mar 2013
MISSION CONTROLS
K033063 · Diamond Diagnostics, Inc. · Dec 2003
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
K022525 · Bio-Rad · Aug 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
K022529 · Bio-Rad · Aug 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
K003239 · Bio-Rad · Nov 2000