Cleared Traditional

K070546 - LYPHOCHEK DIABETES CONTROL (FDA 510(k) Clearance)

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

K070546 · Bio-Rad Laboratories · Chemistry device
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.

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
Regulatory Context
Review time vs. panel average
199d faster than avg
Panel avg: 234d · 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.