Cleared Traditional

K040927 - LINICAL PROTEIN 1 CALIBRATION VERIFIERS...

K040927 is the FDA 510(k) clearance for LINICAL PROTEIN 1 CALIBRATION VERIFIERS... by Cliniqa Corporation. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K040927 · Cliniqa Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
38d
Days
Class 1
Risk

K040927 is an FDA 510(k) clearance for the LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS. 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 May 17, 2004 after a review of 38 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 K040927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2004
Decision Date May 17, 2004
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K040927.
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
K041194 · Medical Analysis Systems, Inc. · Aug 2004
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
K041898 · Cliniqa Corporation · Aug 2004
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
K040918 · Wako Chemicals USA, Inc. · May 2004
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
K041016 · Nova Biomedical Corp. · May 2004
RANDOX LIQUID CRP CONTROLS
K040351 · Randox Laboratories, Ltd. · Mar 2004
R&D GLU-LINE HEMATOLOGY CONTROL
K034048 · R&D Systems, Inc. · Mar 2004