Cleared Traditional

K061056 - RANDOX LIQUID PROTEIN CALIBRATOR

K061056 is an FDA 510(k) clearance for RANDOX LIQUID PROTEIN CALIBRATOR, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Immunology device with product code JIX cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K061056 · Randox Laboratories, Ltd. · Immunology device
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Jul 2006
Decision
94d
Days
Class 2
Risk

K061056 is an FDA 510(k) clearance for the RANDOX LIQUID PROTEIN CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on July 20, 2006 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K061056

510(k) Number K061056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date July 20, 2006
Days to Decision 94 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
11d faster than avg
Panel avg: 105d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 272
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