Cleared Traditional

K042836 - LIQUICHEK RETICULOCYTE CONTROL (A)

K042836 is an FDA 510(k) clearance for LIQUICHEK RETICULOCYTE CONTROL (A), manufactured by Bio-Rad. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K042836 · Bio-Rad · Hematology device
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Nov 2004
Decision
22d
Days
Class 2
Risk

K042836 is an FDA 510(k) clearance for the LIQUICHEK RETICULOCYTE CONTROL (A). Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on November 5, 2004 after a review of 22 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 Bio-Rad devices

FDA 510(k) Submission Details - K042836

510(k) Number K042836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2004
Decision Date November 05, 2004
Days to Decision 22 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
91d faster than avg
Panel avg: 113d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K042836.
IQ BODY FLUIDS CONTROL
K051706 · Streck · Aug 2005
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
K051339 · R&D Systems, Inc. · Jul 2005
ABX ERYTROL
K050721 · Horiba Abx · Jun 2005
RETIC-CHEX FOR CELL-DYN
K042587 · Streck Laboratories, Inc. · Oct 2004
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