Cleared Traditional

K070741 - CLINIQA LIQUID QC UNASSAYED AND ASSAYED...

K070741 is the FDA 510(k) clearance for CLINIQA LIQUID QC UNASSAYED AND ASSAYED... by Cliniqa Corporation. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K070741 · Cliniqa Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
49d
Days
Class 1
Risk

K070741 is an FDA 510(k) clearance for the CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2.... Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Cliniqa Corporation (Fallbrook, US). The FDA issued a Cleared decision on May 4, 2007 after a review of 49 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 K070741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2007
Decision Date May 04, 2007
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K070741.
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892 · Biosite Incorporated · Dec 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
K071980 · Dade Behring, Inc. · Sep 2007
LIQUICHEK TUMOR MARKER CONTROL
K071675 · Bio-Rad Laboratories · Jul 2007
AMMONIA/ALCOHOL CONTROL SET
K070504 · Pointe Scientific, Inc., · Apr 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · Roche Diagnostics Corp. · Mar 2007
AUDIT MICROCV LIPIDS LINEARITY SET (LOW)
K070223 · Aalto Scientific, Ltd. · Mar 2007