Cleared Traditional

K802724 - AMES SERA-PAK URIC ACID REAGENT KIT

K802724 is the FDA 510(k) clearance for AMES SERA-PAK URIC ACID REAGENT KIT by Miles Laboratories, Inc.. It is a Class 1 Hematology device (product code KNK) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K802724 · Miles Laboratories, Inc. · Hematology device
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Dec 1980
Decision
40d
Days
Class 1
Risk

K802724 is an FDA 510(k) clearance for the AMES SERA-PAK URIC ACID REAGENT KIT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1775 - the FDA hematology device 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K802724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1980
Decision Date December 10, 1980
Days to Decision 40 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 113d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNK Acid, Uric, Uricase (colorimetric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KNK Acid, Uric, Uricase (colorimetric)

All 78
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K802724.
WAKO URIC ACID B TEST
K811504 · Wako Chemicals USA, Inc. · Jun 1981
URIC ACID REAGENT SYSTEM
K810136 · American Monitor Corp. · Feb 1981
LANCER URIC ACID AUTO/STAT KIT
K802692 · Sherwood Medical Co. · Dec 1980
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K801649 · Eastman Kodak Company · Aug 1980
SERALYZER URIC ACID REAGENT STRIPS -
K800848 · Miles Laboratories, Inc. · Apr 1980
URIC ACID REAGENT
K791754 · Gilford Diagnostics · Sep 1979