Cleared Traditional

K990980 - BUN, MODEL BU 104-01

K990980 is an FDA 510(k) clearance for BUN, manufactured by A.P. Total Care, 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.

K990980 · A.P. Total Care, Inc. · Chemistry device
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May 1999
Decision
63d
Days
Class 2
Risk

K990980 is an FDA 510(k) clearance for the BUN, MODEL BU 104-01. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 25, 1999 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K990980

510(k) Number K990980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1999
Decision Date May 25, 1999
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.

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 104
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K990980.
WAKO L-TYPE UN TEST
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K992800 · Sigma Diagnostics, Inc. · Sep 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
K982236 · Sigma Diagnostics, Inc. · Aug 1998
UREA
K981918 · Abbott Laboratories · Jul 1998
UREA
K981123 · Trace Scientific , Ltd. · Apr 1998