Cleared Traditional

K885265 - HDL CHOLESTEROL TEST

K885265 is an FDA 510(k) clearance for HDL CHOLESTEROL TEST, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K885265 · Em Diagnostic Systems, Inc. · Chemistry device
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Feb 1989
Decision
50d
Days
Class 1
Risk

K885265 is an FDA 510(k) clearance for the HDL CHOLESTEROL TEST. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 50 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K885265

510(k) Number K885265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1988
Decision Date February 10, 1989
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K885265.
HDL SINGLES
K895381 · Trace America, Inc. · Nov 1989
HDL CHOLESTEROL REAGENT
K891117 · Pointe Scientific, Inc., · Apr 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023 · Sigma Diagnostics, 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 PROCEDURE
K881326 · Data Medical Associates, Inc. · May 1988