Cleared Traditional

BECKMAN HDL CHOLESTEROL REAGENT (K934045) - FDA 510(k) Clearance

Class I Chemistry device.

K934045 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
56d
Days
Class 1
Risk

K934045 is an FDA 510(k) clearance for the BECKMAN HDL CHOLESTEROL REAGENT. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on October 14, 1993 after a review of 56 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K934045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date October 14, 1993
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
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 27
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K934045.
EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
K972041 · Sigma Diagnostics, Inc. · Jul 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · Roche Diagnostic Systems, Inc. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · Technicon Instruments Corp. · Nov 1991
CLINISTAT HDL CHOLESTEROL REAGENT TEST
K895139 · Heraeus Kulzer, Inc. · Dec 1989
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT
K895851 · Beckman Instruments, Inc. · Nov 1989