Cleared Traditional

K041051 - RAICHEM BUN RATE REAGENT (LIQUID)

K041051 is an FDA 510(k) clearance for RAICHEM BUN RATE REAGENT (LIQUID), manufactured by Hemagen Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K041051 · Hemagen Diagnostics, Inc. · Chemistry device
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Jun 2004
Decision
72d
Days
Class 2
Risk

K041051 is an FDA 510(k) clearance for the RAICHEM BUN RATE REAGENT (LIQUID). Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on June 30, 2004 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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.

FDA 510(k) Submission Details - K041051

510(k) Number K041051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2004
Decision Date June 30, 2004
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 89d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 116
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K021385 · Elan Diagnostics · Jul 2002
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K041051 · RAICHEM BUN RATE REAGENT (LIQUID)
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