Cleared Traditional

K010500 - AUTOMATED WORKCELL CONTROL SOFTWARE

K010500 is an FDA 510(k) clearance for AUTOMATED WORKCELL CONTROL SOFTWARE, manufactured by Lab-Interlink, Inc.. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K010500 · Lab-Interlink, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
161d
Days
Class 1
Risk

K010500 is an FDA 510(k) clearance for the AUTOMATED WORKCELL CONTROL SOFTWARE. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Lab-Interlink, Inc. (Omaha, US). The FDA issued a Cleared decision on August 1, 2001 after a review of 161 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Lab-Interlink, Inc. devices

FDA 510(k) Submission Details - K010500

510(k) Number K010500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2001
Decision Date August 01, 2001
Days to Decision 161 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 88d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

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