Cleared Traditional

K080016 - NRBC-CHEX FOR ADVIA

K080016 is an FDA 510(k) clearance for NRBC-CHEX FOR ADVIA, manufactured by Streck. The device is a Class 2 Hematology device with product code GJR cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K080016 · Streck · Hematology device
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
33d
Days
Class 2
Risk

K080016 is an FDA 510(k) clearance for the NRBC-CHEX FOR ADVIA. Classified as Control, Red-cell (product code GJR), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on February 5, 2008 after a review of 33 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.

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FDA 510(k) Submission Details - K080016

510(k) Number K080016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2008
Decision Date February 05, 2008
Days to Decision 33 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
80d faster than avg
Panel avg: 113d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJR Device Classification - Class 2, Special Controls

Product Code GJR Control, Red-cell
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.