Cleared Traditional

K880277 - URIC ACID REAGENT SET

K880277 is an FDA 510(k) clearance for URIC ACID REAGENT SET, manufactured by Tech-Neal Scientific, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K880277 · Tech-Neal Scientific, Inc. · Chemistry device
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Apr 1988
Decision
88d
Days
Class 1
Risk

K880277 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 Tech-Neal Scientific, Inc. (Westmont, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 88 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 Tech-Neal Scientific, Inc. devices

FDA 510(k) Submission Details - K880277

510(k) Number K880277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1988
Decision Date April 18, 1988
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 K880277.
URIC ACID TEST (URIC) ITEM #65620
K884704 · Em Diagnostic Systems, Inc. · Jan 1989
URIC ACID REAGENT (PRODUCT #88219)
K883404 · Hichem Diagnostics · Sep 1988
BIOTROL URIC ACID ENZYMATIQUE TRINDER
K883428 · Biotrol, USA, Inc. · Sep 1988
WAKO AUTOKIT URIC ACID
K880731 · Wako Chemicals USA, Inc. · Mar 1988
PARAMAX URIC ACID REAGENT
K873456 · Baxter Healthcare Corp · Nov 1987
URIC ACID PAP
K873363 · Boehringer Mannheim Corp. · Oct 1987