Cleared Traditional

K980057 - CARESIDE BUN

K980057 is an FDA 510(k) clearance for CARESIDE BUN, manufactured by Exigent Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K980057 · Exigent Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
30d
Days
Class 2
Risk

K980057 is an FDA 510(k) clearance for the CARESIDE BUN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Exigent Diagnostics, Inc. (Culver City, US). The FDA issued a Cleared decision on February 5, 1998 after a review of 30 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 Exigent Diagnostics, Inc. devices

FDA 510(k) Submission Details - K980057

510(k) Number K980057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1998
Decision Date February 05, 1998
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 105
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K980057.
UREA
K981918 · Abbott Laboratories · Jul 1998
UREA
K981123 · Trace Scientific , Ltd. · Apr 1998
UREA NITROGEN (BUN) LIQUID REAGENT
K981106 · Teco Diagnostics · Apr 1998
IL TEST UREA NITROGEN
K974337 · Instrumentation Laboratory CO · Dec 1997
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
K973931 · Diagnostic Chemicals , Ltd. · Nov 1997
UREA
K971309 · Derma Media Lab., Inc. · Aug 1997