Cleared Traditional

K894110 - QUALICHECK 2

K894110 is an FDA 510(k) clearance for QUALICHECK 2, 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 52-day FDA review.

K894110 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
52d
Days
Class 1
Risk

K894110 is an FDA 510(k) clearance for the QUALICHECK 2. 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 August 3, 1989 after a review of 52 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 - K894110

510(k) Number K894110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1989
Decision Date August 03, 1989
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
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 K894110.
BLOOD GAS CONTROLS
K901985 · Phoenix Diagnostics, Inc. · Jun 1990
BLOOD GAS/CO-OXIMETRY CONTROL
K901976 · Phoenix Diagnostics, Inc. · May 1990
CO-OXIMETER CONTROLS
K901986 · Phoenix Diagnostics, Inc. · May 1990
MULTI-FUNCTION BLOOD GAS CONTROL
K874408 · Bionostics, Inc. · Dec 1987
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196 · American Dade · Jul 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · Ciba Corning Diagnostics Corp. · Jan 1987