Cleared Traditional

K130253 - TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION (FDA 510(k) Clearance)

Class I Immunology device.

K130253 · Beckman Coulter, Inc. · Immunology device
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Jul 2013
Decision
164d
Days
Class 1
Risk

K130253 is an FDA 510(k) clearance for the TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION. Classified as Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (product code PER), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 15, 2013 after a review of 164 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2750 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K130253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2013
Decision Date July 15, 2013
Days to Decision 164 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 104d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
Definition Flow Cytometer Specimen Processors Are Automated Or Semi-automated Workstations Designed To Be Used Alone Or In Combination With Manual Methods To Pipette, Dilute And Process Human Specimens In Preparation For Flow Cytometric Analysis.
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.