Cleared Special

K021922 - MODIFICATION TO PARA 5X

K021922 is the FDA 510(k) clearance for MODIFICATION TO PARA 5X by Streck Laboratories, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Special 510(k) pathway after a 14-day FDA review.

K021922 · Streck Laboratories, Inc. · Hematology device
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Jun 2002
Decision
14d
Days
Class 2
Risk

K021922 is an FDA 510(k) clearance for the MODIFICATION TO 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 25, 2002 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Streck Laboratories, Inc. devices

Submission Details

510(k) Number K021922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2002
Decision Date June 25, 2002
Days to Decision 14 days
Submission Type Special
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
99d faster than avg
Panel avg: 113d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K021922.
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · Bio-Rad Laboratories, Inc. · Oct 2004
R&D CBC-XE HEMATOLOGY CONTROL
K042094 · R&D Systems, Inc. · Sep 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · Bio-Rad · Jun 2004
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