Cleared Traditional

K771509 - MULTISTAT III URIC ACID TEST

K771509 is an FDA 510(k) clearance for MULTISTAT III URIC ACID TEST, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Chemistry device with product code CDO cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K771509 · Instrumentation Laboratory CO · Chemistry device
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Sep 1977
Decision
39d
Days
Class 1
Risk

K771509 is an FDA 510(k) clearance for the MULTISTAT III URIC ACID TEST. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977 after a review of 39 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K771509

510(k) Number K771509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1977
Decision Date September 13, 1977
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

CDO Device Classification - Class 1, General Controls

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 26
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K771509.
UV URIC ACID DETERMINATION
K790834 · The Dow Chemical Co. · Jun 1979
ACID REAGENT, URIC SINGLE VIAL
K781996 · Calbiochem-Behring Corp. · Jan 1979
PRINCETON BIOMEDIX URICASE (UV)
K780859 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1978
IN VITRO DIAG. FOR URIC ACID
K770767 · Smithkline Diagnostics, Inc. · Jul 1977