Cleared Traditional

K871265 - ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL (FDA 510(k) Clearance)

Class I Chemistry device.

K871265 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Aug 1987
Decision
135d
Days
Class 1
Risk

K871265 is an FDA 510(k) clearance for the ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on August 13, 1987 after a review of 135 days - within the typical 510(k) review window.

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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K871265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1987
Decision Date August 13, 1987
Days to Decision 135 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 88d · This submission: 135d
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.