Cleared Traditional

K013332 - LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE

K013332 is an FDA 510(k) clearance for LINICAL PROTEIN I CALIBRATION VERIFIERS..., manufactured by Cliniqa Corporation. The device is a Class 1 Immunology device with product code JJY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K013332 · Cliniqa Corporation · Immunology device
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Nov 2001
Decision
42d
Days
Class 1
Risk

K013332 is an FDA 510(k) clearance for the LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE. 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 November 20, 2001 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 - K013332

510(k) Number K013332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date November 20, 2001
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 105d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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 593
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