Cleared Traditional

ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE (K864522) - FDA 510(k) Clearance

Class I Chemistry device.

K864522 · Beckman Instruments, Inc. · Chemistry device
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Feb 1987
Decision
79d
Days
Class 1
Risk

K864522 is an FDA 510(k) clearance for the ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE. 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 February 4, 1987 after a review of 79 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 K864522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1986
Decision Date February 04, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K864522.
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1987
PARAMAX CHOLESTEROL REAGENT
K872050 · American Dade · Jul 1987
VISION (TM) HDL CHOLESTEROL
K871461 · Abbott Laboratories · May 1987
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845 · Em Diagnostic Systems, Inc. · Aug 1986
TECHNICON HDL CHOLESTEROL METHOD
K791990 · Technicon Instruments Corp. · Oct 1979
CHOLESTEROL KIT, HDL-DS
K790553 · Beckman Instruments, Inc. · Jun 1979