Cleared Traditional

K861831 - REFLOTRON URIC ACID

K861831 is an FDA 510(k) clearance for REFLOTRON URIC ACID, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K861831 · Boehringer Mannheim Corp. · Chemistry device
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Jul 1986
Decision
59d
Days
Class 1
Risk

K861831 is an FDA 510(k) clearance for the REFLOTRON URIC ACID. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 59 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K861831

510(k) Number K861831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1986
Decision Date July 11, 1986
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
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 83
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K861831.
URIC ACID
K863924 · Tech-Co, Inc. · Nov 1986
URIC ACID PROCEDURE
K863251 · Data Medical Associates, Inc. · Sep 1986
URICMETER
K863113 · J. D. Assoc. · Sep 1986
KING DIAGNOSTICS URIC ACID TEST
K862208 · King Diagnostics, Inc. · Jul 1986
URIC ACID PROCEDURE
K861660 · Data Medical Associates, Inc. · Jun 1986
ENZYMATIC URIC ACID REAGENT
K860732 · Trace Scientific , Ltd. · Apr 1986