Cleared Traditional

K801269 - SERALYZER BLOOD UREA NITROGEN(BUN)

K801269 is an FDA 510(k) clearance for SERALYZER BLOOD UREA NITROGEN(BUN), manufactured by Miles Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JGZ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K801269 · Miles Laboratories, Inc. · Chemistry device
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Jul 1980
Decision
41d
Days
Class 2
Risk

K801269 is an FDA 510(k) clearance for the SERALYZER BLOOD UREA NITROGEN(BUN). Classified as O-phthalaldehyde, Urea Nitrogen (product code JGZ), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 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.

FDA 510(k) Submission Details - K801269

510(k) Number K801269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1980
Decision Date July 08, 1980
Days to Decision 41 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
48d faster than avg
Panel avg: 89d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGZ Device Classification - Class 2, Special Controls

Product Code JGZ O-phthalaldehyde, 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 - JGZ O-phthalaldehyde, Urea Nitrogen

All 10
Devices cleared under the same product code (JGZ) and FDA review panel - the closest regulatory comparables to K801269.
BLOOD UREA NITROGEN REAGENT SYS
K840213 · Sclavo, Inc. · Mar 1984
K.D. COLORIMETRIC BLOOD UREA N2 TEST
K820418 · King Diagnostics, Inc. · Mar 1982
UREA NITROGEN, KINETIC
K810087 · Bio-Analytics Laboratories, Inc. · Feb 1981
BLOOD UREA NITROGEN REAGENT
K792362 · Connecticut Diagnostics, Ltd. · Dec 1979
REAGENT SYSTEM
K770504 · American Monitor Corp. · Jun 1977
K801269 · SERALYZER BLOOD UREA NITROGEN(BUN)
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