Cleared Traditional

K150300 - Liquichek Cardiac Markers Plus Control LT (FDA 510(k) Clearance)

Class I Chemistry device.

K150300 · Bio-Rad Laboratories · Chemistry device
Dec 2015
Decision
308d
Days
Class 1
Risk

K150300 is an FDA 510(k) clearance for the Liquichek Cardiac Markers Plus Control LT. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on December 11, 2015 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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

Submission Details

510(k) Number K150300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2015
Decision Date December 11, 2015
Days to Decision 308 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 234d · This submission: 308d
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.