Cleared Traditional

K091303 - LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091303 · Bio-Rad Laboratories · Hematology device
Aug 2010
Decision
455d
Days
Class 2
Risk

K091303 is an FDA 510(k) clearance for the LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on August 2, 2010 after a review of 455 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

Submission Details

510(k) Number K091303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2009
Decision Date August 02, 2010
Days to Decision 455 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 205d · This submission: 455d
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.