Cleared Traditional

ENZYMATIC UREA NITROGEN REAGENT SET (K860109) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860109 · Technostics Intl. · Chemistry device
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Feb 1986
Decision
24d
Days
Class 2
Risk

K860109 is an FDA 510(k) clearance for the ENZYMATIC UREA NITROGEN REAGENT SET. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 24 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 Technostics Intl. devices

Submission Details

510(k) Number K860109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1986
Decision Date February 06, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 33
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K860109.
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · Em Diagnostic Systems, Inc. · Mar 1987
BUN (RATE) REAGENT
K863196 · Sigma Diagnostics, Inc. · Aug 1986
EASY-TEST UREA (BUN) REAGENT
K860135 · Em Diagnostic Systems, Inc. · Feb 1986
TDX REA BUN
K853677 · Abbott Laboratories · Sep 1985
BUN(ENDPOINT) REAGENT
K852131 · Sigma Diagnostics, Inc. · Jun 1985
BUN (RATE) REAGENT
K850923 · Sigma Diagnostics, Inc. · Mar 1985