Cleared Traditional

K881244 - HDL CHOLESTEROL KIT

K881244 is the FDA 510(k) clearance for HDL CHOLESTEROL KIT by Trace Scientific , Ltd.. It is a Class 1 Chemistry device (product code LBR) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K881244 · Trace Scientific , Ltd. · Chemistry device
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Jun 1988
Decision
79d
Days
Class 1
Risk

K881244 is an FDA 510(k) clearance for the HDL CHOLESTEROL KIT. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on June 10, 1988 after a review of 79 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K881244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1988
Decision Date June 10, 1988
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 33
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K881244.
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023 · Sigma Diagnostics, Inc. · Feb 1989
HDL CHOLESTEROL TEST
K885265 · Em Diagnostic Systems, Inc. · Feb 1989
IQ HDL CHOLESTEROL
K883353 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
HDL CHOLESTEROL PRECIPITATING PROCEDURE
K881326 · Data Medical Associates, Inc. · May 1988
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176 · Tech-Co, Inc. · Feb 1988
HDL CHOLESTEROL PRETREATMENT
K852350 · American Monitor Corp. · Jul 1985