Cleared Traditional

K012649 - RAICHEM BUN RATE REAGENT

K012649 is the FDA 510(k) clearance for RAICHEM BUN RATE REAGENT by Hemagen Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K012649 · Hemagen Diagnostics, Inc. · Chemistry device
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Oct 2001
Decision
63d
Days
Class 2
Risk

K012649 is an FDA 510(k) clearance for the RAICHEM BUN RATE REAGENT. 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 October 15, 2001 after a review of 63 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.

View all Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K012649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date October 15, 2001
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 87
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K012649.
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