Cleared Traditional

K071706 - ENVOY 500 HDL (FDA 510(k) Clearance)

Also includes:
CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

Class I Chemistry device.

K071706 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
182d
Days
Class 1
Risk

K071706 is an FDA 510(k) clearance for the ENVOY 500 HDL. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 182 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K071706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2007
Decision Date December 20, 2007
Days to Decision 182 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 88d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.