Cleared Traditional

K013898 - R&D RET-LINE KIT

K013898 is the FDA 510(k) clearance for R&D RET-LINE KIT by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K013898 · R&D Systems, Inc. · Hematology device
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Jan 2002
Decision
60d
Days
Class 2
Risk

K013898 is an FDA 510(k) clearance for the R&D RET-LINE KIT. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 22, 2002 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - the FDA hematology 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: 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 R&D Systems, Inc. devices

Submission Details

510(k) Number K013898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date January 22, 2002
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 113d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K013898.
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · Bio-Rad · Jun 2004
MODIFICATION TO PARA 5X
K021922 · Streck Laboratories, Inc. · Jun 2002
R & D BODY FLUID CONTROL
K020229 · R&D Systems, Inc. · Feb 2002
IMMUNO-TROL LOW CELLS
K013842 · Beckman Coulter, Inc. · Dec 2001
PARA 5X
K011410 · Streck Laboratories, Inc. · Jun 2001
R & D 4K RETIC
K010470 · R&D Systems, Inc. · May 2001