Cleared Traditional

SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798) - FDA 510(k) Clearance

Class I Chemistry device.

K992798 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
40d
Days
Class 1
Risk

K992798 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-50.... Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 28, 1999 after a review of 40 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K992798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1999
Decision Date September 28, 1999
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDO Acid, Uric, Uricase (u.v.)
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 - CDO Acid, Uric, Uricase (u.v.)

All 30
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K992798.
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