Cleared Traditional

K914511 - TECHNICON AXON(TM) SYSTEM METHODS ANYAL...

K914511 is the FDA 510(k) clearance for TECHNICON AXON(TM) SYSTEM METHODS ANYAL... by Technicon Instruments Corp.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K914511 · Technicon Instruments Corp. · Chemistry device
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Nov 1991
Decision
49d
Days
Class 1
Risk

K914511 is an FDA 510(k) clearance for the TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 49 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K914511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1991
Decision Date November 27, 1991
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, 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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 47
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K914511.
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · Randox Laboratories, Ltd. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
BECKMAN HDL CHOLESTEROL REAGENT
K934045 · Beckman Instruments, Inc. · Oct 1993
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · Immunotech Corp. · Mar 1990
CLINISTAT HDL CHOLESTEROL REAGENT TEST
K895139 · Heraeus Kulzer, Inc. · Dec 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851 · Beckman Instruments, Inc. · Nov 1989