Cleared Traditional

K822913 - URIC ACID REAGENT

K822913 is an FDA 510(k) clearance for URIC ACID REAGENT, manufactured by Ac Biochemical Laboratories, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K822913 · Ac Biochemical Laboratories, Inc. · Chemistry device
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Dec 1982
Decision
80d
Days
Class 1
Risk

K822913 is an FDA 510(k) clearance for the URIC ACID REAGENT. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Ac Biochemical Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on December 20, 1982 after a review of 80 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 Ac Biochemical Laboratories, Inc. devices

FDA 510(k) Submission Details - K822913

510(k) Number K822913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1982
Decision Date December 20, 1982
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

KNK Device Classification - Class 1, General Controls

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 101
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K822913.
DATA-ZYME URIC ACID PROCEDURE
K831983 · Data Medical Associates, Inc. · Aug 1983
URIC-ACID TEST ENZYMATIC COLORIMETRIC
K831864 · Stanbio Laboratory · Jul 1983
LINEAR ENZMATIC URIC ACID SYSTEM
K831398 · Simmler, Inc. · Jun 1983
URICACID
K821741 · Biodynamics Corp. · Jul 1982
BECKMAN URIC ACID REAGENT
K821812 · Beckman Instruments, Inc. · Jul 1982
URIC ACID REAGENT SET(ENZYMATIC
K821214 · Omega Medical Electronics · May 1982