Cleared Traditional

K000331 - SYNCHRON LX SYSTEMS MICROALBUMIN CALIBR...

K000331 is the FDA 510(k) clearance for SYNCHRON LX SYSTEMS MICROALBUMIN CALIBR... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K000331 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
50d
Days
Class 2
Risk

K000331 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 10, 2000 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Coulter, Inc. devices

Submission Details

510(k) Number K000331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1999
Decision Date February 10, 2000
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K000331.
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