Cleared Traditional

K924129 - MILES AUTO METH DETERMIN OF URIC ACID IN URINE

K924129 is an FDA 510(k) clearance for MILES AUTO METH DETERMIN OF URIC ACID I..., manufactured by Heraeus Kulzer, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K924129 · Heraeus Kulzer, Inc. · Chemistry device
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Sep 1992
Decision
36d
Days
Class 1
Risk

K924129 is an FDA 510(k) clearance for the MILES AUTO METH DETERMIN OF URIC ACID IN URINE. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 36 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K924129

510(k) Number K924129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1992
Decision Date September 22, 1992
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 100
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K924129.
URIC ACID ENZYMATIC COLORIMERIC KIT
K923503 · Randox Laboratories, Ltd. · Jul 1993
OLYMPUS URIC ACID REAGENT
K925113 · Olympus Corp. · Jan 1993
SYNERMED 600 NM URIC ACID REAGENT KIT
K923414 · Synermed, Inc. · Sep 1992
OLYMPUS URIC ACID REAGENT
K922756 · Olympus Corp. · Jul 1992
ROCHE REAGENT FOR URIC ACID--MODIFICATION
K922762 · Roche Diagnostic Systems, Inc. · Jul 1992
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · Em Diagnostic Systems, Inc. · Sep 1991