Cleared Traditional

K022232 - CLINIQA LIQUID-QC HCG CONTROL LEVEL 1

K022232 is the FDA 510(k) clearance for CLINIQA LIQUID-QC HCG CONTROL LEVEL 1 by Cliniqa Corporation. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K022232 · Cliniqa Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
22d
Days
Class 1
Risk

K022232 is an FDA 510(k) clearance for the CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 22 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 Cliniqa Corporation devices

Submission Details

510(k) Number K022232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2002
Decision Date August 01, 2002
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K022232.
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
K023307 · Medical Analysis Systems, Inc. · Oct 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
K022758 · Cliniqa Corporation · Sep 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
K022491 · Cliniqa Corporation · Aug 2002
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624 · Bionostics, Inc. · Jul 2002
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697 · Bionostics, Inc. · Jul 2002
ELECSYS ANTI-TG CALCHECK
K020369 · Roche Diagnostics Corp. · Mar 2002