Cleared Traditional

K021316 - ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2

Also marketed or referenced as:
ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

K021316 is an FDA 510(k) clearance for ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT..., manufactured by Genzyme Corp.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K021316 · Genzyme Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
91d
Days
Class 1
Risk

K021316 is an FDA 510(k) clearance for the ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on July 25, 2002 after a review of 91 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 Genzyme Corp. devices

FDA 510(k) Submission Details - K021316

510(k) Number K021316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2002
Decision Date July 25, 2002
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LBS Device Classification - Class 1, General Controls

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.

Regulatory Peers - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 71
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K021316.
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · Stanbio Laboratory · Mar 2004
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · Roche Diagnostics Corp. · Dec 2003
PICCOLO HDL TEST SYSTEM
K023640 · Abaxis, Inc. · Jan 2003
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · Jas Diagnostics, Inc. · Jul 2002
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · Olympus America, Inc. · Feb 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032 · Olympus America, Inc. · Feb 2002