Cleared Traditional

K072721 - LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT...

K072721 is the FDA 510(k) clearance for LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT... by Bio-Rad, Diagnostics Grp.. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K072721 · Bio-Rad, Diagnostics Grp. · Chemistry device
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Dec 2007
Decision
76d
Days
Class 1
Risk

K072721 is an FDA 510(k) clearance for the LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad, Diagnostics Grp. (Irvine, US). The FDA issued a Cleared decision on December 11, 2007 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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, Diagnostics Grp. devices

Submission Details

510(k) Number K072721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2007
Decision Date December 11, 2007
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 147
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K060788 · Biosite Incorporated · Jul 2006