Cleared Traditional

K052679 - CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3

Also marketed or referenced as:
CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E

K052679 is an FDA 510(k) clearance for CLINIQA LIQUID QC BILIRUBIN CONTROLS LE..., manufactured by Cliniqa Corporation. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K052679 · Cliniqa Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
51d
Days
Class 1
Risk

K052679 is an FDA 510(k) clearance for the CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 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 November 18, 2005 after a review of 51 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

FDA 510(k) Submission Details - K052679

510(k) Number K052679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date November 18, 2005
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 444
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