Cleared Traditional

K982236 - SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT

K982236 is the FDA 510(k) clearance for SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K982236 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
41d
Days
Class 2
Risk

K982236 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 5, 1998 after a review of 41 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K982236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1998
Decision Date August 05, 1998
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 K982236.
WAKO L-TYPE UN TEST
K993925 · Wako Chemicals USA, Inc. · Apr 2000
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
K993178 · Diagnostic Chemicals , Ltd. · Oct 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
K992800 · Sigma Diagnostics, Inc. · Sep 1999
UREA
K981918 · Abbott Laboratories · Jul 1998
UREA
K981123 · Trace Scientific , Ltd. · Apr 1998
UREA NITROGEN (BUN) LIQUID REAGENT
K981106 · Teco Diagnostics · Apr 1998