Cleared Traditional

AUTOHDL CHOLESTEROL REAGENT SET (K992002) - FDA 510(k) Clearance

Class I Chemistry device.

K992002 · Pointe Scientific, Inc., · Chemistry device
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Aug 1999
Decision
51d
Days
Class 1
Risk

K992002 is an FDA 510(k) clearance for the AUTOHDL CHOLESTEROL REAGENT SET. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 51 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K992002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1999
Decision Date August 05, 1999
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 65
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K992002.
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · Boehringer Mannheim Corp. · Jan 1998
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · Roche Diagnostic Systems, Inc. · Nov 1997
IL TEST(TM) HDL CHOLESTEROL
K914811 · Instrumentation Laboratory CO · Jan 1992
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · Boehringer Mannheim Corp. · Aug 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · Roche Diagnostic Systems, Inc. · Mar 1990
HDL CHOLESTEROL TEST
K885265 · Em Diagnostic Systems, Inc. · Feb 1989