Cleared Traditional

K962186 - N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

K962186 is an FDA 510(k) clearance for N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTER..., manufactured by Genzyme Corp.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K962186 · Genzyme Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
74d
Days
Class 1
Risk

K962186 is an FDA 510(k) clearance for the N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on August 19, 1996 after a review of 74 days - a notably fast clearance 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: 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 Genzyme Corp. devices

FDA 510(k) Submission Details - K962186

510(k) Number K962186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1996
Decision Date August 19, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

Product Code LBR Ldl & Vldl Precipitation, 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.

Regulatory Peers - LBR Ldl & Vldl Precipitation, Hdl

All 53
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K962186.
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · Roche Diagnostic Systems, Inc. · Nov 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K971573 · Genzyme Corp. · Jun 1997
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN
K962723 · Trace America, Inc. · Mar 1997
HDL PRECIPITATING REAGENT
K954179 · Schiapparelli Biosystems, Inc. · Dec 1995
MAGNETIC HDL CHOLESTEROL TEST
K944975 · Reference Diagnostics, Inc. · Aug 1995
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1993