Cleared Traditional

K854406 - TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500

K854406 is the FDA 510(k) clearance for TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 by Tecan U.S., Ltd.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K854406 · Tecan U.S., Ltd. · Chemistry device
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Feb 1986
Decision
101d
Days
Class 1
Risk

K854406 is an FDA 510(k) clearance for the TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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 Tecan U.S., Ltd. devices

Submission Details

510(k) Number K854406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1985
Decision Date February 10, 1986
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 64
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K854406.
ULTRAWASH II
K863624 · Dynatech Laboratories, Inc. · Oct 1986
SURESPOT
K862701 · Helena Laboratories · Aug 1986
POSID SAMPLER
K860508 · Organon Teknika Corp. · May 1986
DADE BLOOD GAS AMPUL INJECTOR
K852285 · American Dade · Jul 1985
VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
K851403 · Ventrex Laboratories, Inc. · Jun 1985
AUTOLOADER II
K843779 · Electro-Nucleonics Laboratories, Inc. · Jan 1985