Cleared Traditional

K083554 - CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LE...

K083554 is the FDA 510(k) clearance for CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LE... by Cliniqa Corporation. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K083554 · Cliniqa Corporation · Chemistry device
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Apr 2009
Decision
141d
Days
Class 1
Risk

K083554 is an FDA 510(k) clearance for the CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on April 21, 2009 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Cliniqa Corporation devices

Submission Details

510(k) Number K083554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2008
Decision Date April 21, 2009
Days to Decision 141 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
53d slower than avg
Panel avg: 88d · This submission: 141d
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)

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