Cleared Traditional

LPC II (K812031) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812031 · Labtronix Corp. · Hematology device
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Aug 1981
Decision
23d
Days
Class 2
Risk

K812031 is an FDA 510(k) clearance for the LPC II. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Labtronix Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology device 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 Labtronix Corp. devices

Submission Details

510(k) Number K812031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1981
Decision Date August 12, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 113d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 24
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K812031.
FACS ANALYZER
K832420 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
QBC CENTRIFUGAL HEMATOLOGY SYS
K830451 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1983
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978 · Technicon Instruments Corp. · Aug 1981
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155 · Technicon Instruments Corp. · Jun 1980
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
K771728 · Technicon Instruments Corp. · Nov 1977
HEMALOG 8/90
K770666 · Technicon Instruments Corp. · May 1977