Cleared Traditional

K902568 - REFLOTRON HDL CHOLESTEROL TEST TABS

K902568 is an FDA 510(k) clearance for REFLOTRON HDL CHOLESTEROL TEST TABS, manufactured by Boehringer Mannheim Corp.. 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.

K902568 · Boehringer Mannheim Corp. · Chemistry device
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Aug 1990
Decision
59d
Days
Class 1
Risk

K902568 is an FDA 510(k) clearance for the REFLOTRON HDL CHOLESTEROL TEST TABS. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 9, 1990 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K902568

510(k) Number K902568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1990
Decision Date August 09, 1990
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 38
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K902568.
HIGH DENSITY LIPOPROTEIN CHOLESTEROL
K912823 · Creative Laboratory Products, Inc. · Aug 1991
HDL CHOLESTEROL REAGENT
K911406 · Genzyme Corp. · May 1991
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284 · Amresco, Inc. · Dec 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174 · Coulter Corp. · Jul 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · Roche Diagnostic Systems, Inc. · Mar 1990
HDL CHOLESTEROL REAGENT
K891117 · Pointe Scientific, Inc., · Apr 1989