Cleared Traditional

K012649 - RAICHEM BUN RATE REAGENT

K012649 is an FDA 510(k) clearance for RAICHEM BUN RATE REAGENT, 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 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.

FDA 510(k) Submission Details - K012649

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
26d faster than avg
Panel avg: 89d · This submission: 63d
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
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K012649.
RAICHEM BUN RATE REAGENT (LIQUID)
K041051 · Hemagen Diagnostics, Inc. · Jun 2004
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
K024182 · Precision Systems, Inc. · Mar 2003
ATAC PAK BUN REAGENT
K021385 · Elan Diagnostics · Jul 2002
WIENER LAB. UREA UV CINETICA AA
K012260 · Wiener Laboratories Saic · Sep 2001
UREA NITROGEN (BUN) LIQUID REAGENT
K011596 · Jas Diagnostic, Inc. · Jul 2001
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · Diagnostic Chemicals , Ltd. · Sep 2000
K012649 · RAICHEM BUN RATE REAGENT
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