Cleared Traditional

K812430 - URIC ACID REAGENT SET

K812430 is the FDA 510(k) clearance for URIC ACID REAGENT SET by Pointe Scientific, Inc.,. It is a Class 1 Chemistry device (product code KNK) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K812430 · Pointe Scientific, Inc., · Chemistry device
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Sep 1981
Decision
15d
Days
Class 1
Risk

K812430 is an FDA 510(k) clearance for the URIC ACID REAGENT SET. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K812430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1981
Decision Date September 09, 1981
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K812430.
URIC ACID SYSTEM PACK TEST
K812978 · Boehringer Mannheim Corp. · Nov 1981
URICAR
K812700 · Hi Chem, Inc. · Nov 1981
URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM
K812641 · Reagents Applications, Inc. · Oct 1981
URIC ACID TEST
K811687 · King Diagnostics, Inc. · Jul 1981
WAKO URIC ACID B TEST
K811504 · Wako Chemicals USA, Inc. · Jun 1981
URIC ACID REAGENT SYSTEM
K810136 · American Monitor Corp. · Feb 1981