Cleared Traditional

K011410 - PARA 5X

K011410 is the FDA 510(k) clearance for PARA 5X by Streck Laboratories, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K011410 · Streck Laboratories, Inc. · Hematology device
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Jun 2001
Decision
49d
Days
Class 2
Risk

K011410 is an FDA 510(k) clearance for the PARA 5X. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on June 26, 2001 after a review of 49 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 Streck Laboratories, Inc. devices

Submission Details

510(k) Number K011410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2001
Decision Date June 26, 2001
Days to Decision 49 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
64d faster than avg
Panel avg: 113d · This submission: 49d
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 K011410.
R & D BODY FLUID CONTROL
K020229 · R&D Systems, Inc. · Feb 2002
R&D RET-LINE KIT
K013898 · R&D Systems, Inc. · Jan 2002
IMMUNO-TROL LOW CELLS
K013842 · Beckman Coulter, Inc. · Dec 2001
R & D 4K RETIC
K010470 · R&D Systems, Inc. · May 2001
ADVIA RETIC PLUS
K010461 · R&D Systems, Inc. · Apr 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · Quantimetrix Corp. · Mar 2001