Cleared Traditional

K812341 - UREA NITROGEN (BUN)

K812341 is the FDA 510(k) clearance for UREA NITROGEN (BUN) by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812341 · Pointe Scientific, Inc., · Chemistry device
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Sep 1981
Decision
14d
Days
Class 2
Risk

K812341 is an FDA 510(k) clearance for the UREA NITROGEN (BUN). Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on September 1, 1981 after a review of 14 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K812341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1981
Decision Date September 01, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 K812341.
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&
K823402 · Emd Chemicals, Inc. · Dec 1982
LANCER MSA BUN DIAG. KIT
K821562 · Sherwood Medical Co. · Jun 1982
BLOOD UREA NITROGEN(BUN-UV)
K812417 · Reagents Applications, Inc. · Sep 1981
FUN-UV SYSTEM PACK TEST
K812290 · Boehringer Mannheim Corp. · Aug 1981
A-GENT UREA NITROGEN
K810794 · Abbott Laboratories · Apr 1981
DATA-ZYME UREA NITROGEN REAGENT SET
K802061 · Data Medical Associates, Inc. · Sep 1980