Cleared Traditional

IQ HDL CHOLESTEROL (K883353) - FDA 510(k) Clearance

Class I Chemistry device.

K883353 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Sep 1988
Decision
35d
Days
Class 1
Risk

K883353 is an FDA 510(k) clearance for the IQ HDL CHOLESTEROL. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 35 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K883353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date September 13, 1988
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 10
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K883353.
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · Roche Diagnostic Systems, Inc. · Mar 1990
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023 · Sigma Diagnostics, Inc. · Feb 1989
HDL CHOLESTEROL TEST
K885265 · Em Diagnostic Systems, Inc. · Feb 1989
LANCER HDL SEPARATION KIT
K790865 · Sherwood Medical Co. · Jun 1979
A-GENT-HDL REAGENT
K790329 · Abbott Laboratories · Apr 1979
HDL CENTRIFIKIT
K781093 · Beckman Instruments, Inc. · Aug 1978