Cleared Traditional

K992002 - AUTOHDL CHOLESTEROL REAGENT SET

K992002 is an FDA 510(k) clearance for AUTOHDL CHOLESTEROL REAGENT SET, manufactured by Pointe Scientific, Inc.,. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 51-day FDA review.

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

FDA 510(k) Submission Details - K992002

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
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 K992002.
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
K023784 · Hemagen Diagnostics, Inc. · Dec 2002
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
K012593 · Ortho-Clinical Diagnostics, Inc. · Aug 2001
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K992029 · Elan Diagnostics · Aug 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K991789 · Elan Holdings, Inc. · Jul 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
K990247 · Polymer Technology Systems, Inc. · May 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · Ortho-Clinical Diagnostics, Inc. · Jan 1999