Cleared Traditional

K872484 - MODIFIED ENZYMATIC BUN REAGENT

K872484 is the FDA 510(k) clearance for MODIFIED ENZYMATIC BUN REAGENT by Trace Scientific , Ltd.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K872484 · Trace Scientific , Ltd. · Chemistry device
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Aug 1987
Decision
56d
Days
Class 2
Risk

K872484 is an FDA 510(k) clearance for the MODIFIED ENZYMATIC BUN REAGENT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Trace Scientific , Ltd. (Miami Lakes, US). The FDA issued a Cleared decision on August 19, 1987 after a review of 56 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K872484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1987
Decision Date August 19, 1987
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 K872484.
PARAMAX UREA NITROGEN REAGENT
K873532 · Baxter Healthcare Corp · Nov 1987
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
K874477 · Em Diagnostic Systems, Inc. · Nov 1987
WAKO(TM) AUTOKIT UREA N
K873335 · Wako Chemicals USA, Inc. · Oct 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · Em Diagnostic Systems, Inc. · Mar 1987
UREA NITROGEN(BUN)
K863925 · Tech-Co, Inc. · Nov 1986
BLOOD UREA NITROGEN(BUN) PROCEDURE
K863260 · Data Medical Associates, Inc. · Sep 1986