Cleared Traditional

K881326 - HDL CHOLESTEROL PRECIPITATING PROCEDURE

K881326 is an FDA 510(k) clearance for HDL CHOLESTEROL PRECIPITATING PROCEDURE, manufactured by Data Medical Associates, Inc.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K881326 · Data Medical Associates, Inc. · Chemistry device
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May 1988
Decision
59d
Days
Class 1
Risk

K881326 is an FDA 510(k) clearance for the HDL CHOLESTEROL PRECIPITATING PROCEDURE. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 59 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 Data Medical Associates, Inc. devices

FDA 510(k) Submission Details - K881326

510(k) Number K881326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1988
Decision Date May 27, 1988
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 K881326.
HDL CHOLESTEROL TEST
K885265 · Em Diagnostic Systems, Inc. · Feb 1989
IQ HDL CHOLESTEROL
K883353 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
HDL CHOLESTEROL KIT
K881244 · Trace Scientific , Ltd. · Jun 1988
HDL CHOLESTEROL PRECIPITATING REAGENT
K880176 · Tech-Co, Inc. · Feb 1988
MULTICHEM HDL PRECIPITATING REAGENT #S0914
K874820 · Simmler, Inc. · Jan 1988
WORTHINGTON HDL PRECIPITATING REAGENT SET
K861926 · Cooper Biomedical, Inc. · Jun 1986