Cleared Traditional

K070546 - LYPHOCHEK DIABETES CONTROL

K070546 is the FDA 510(k) clearance for LYPHOCHEK DIABETES CONTROL by Bio-Rad Laboratories. It is a Class 2 Chemistry device (product code GGM) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K070546 · Bio-Rad Laboratories · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
35d
Days
Class 2
Risk

K070546 is an FDA 510(k) clearance for the LYPHOCHEK DIABETES CONTROL. Classified as Control, Hemoglobin (product code GGM), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on April 2, 2007 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.8625 - the FDA in vitro diagnostics and chemistry 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 Laboratories devices

Submission Details

510(k) Number K070546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2007
Decision Date April 02, 2007
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
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: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGM Control, Hemoglobin
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 Chemistry devices follow this clearance model.

Regulatory Peers - GGM Control, Hemoglobin

All 8
Devices cleared under the same product code (GGM) and FDA review panel - the closest regulatory comparables to K070546.
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K192842 · Eurotrol B.V. · Nov 2019
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
K182744 · Eurotrol B.V. · Feb 2019
R&D SICKLE QC CONTROL
K070334 · R&D Systems, Inc. · Mar 2007
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · Bio-Rad · Nov 2005
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · Bio-Rad · Nov 2000
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · R&D Systems, Inc. · Nov 1999