Cleared Traditional

K800190 - STANBIO DIRECT URIC ACID TEST SET #0770

K800190 is the FDA 510(k) clearance for STANBIO DIRECT URIC ACID TEST SET #0770 by Stanbio Laboratory. It is a Class 1 Chemistry device (product code CDH) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800190 · Stanbio Laboratory · Chemistry device
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Feb 1980
Decision
15d
Days
Class 1
Risk

K800190 is an FDA 510(k) clearance for the STANBIO DIRECT URIC ACID TEST SET #0770. Classified as Acid, Uric, Phosphotungstate Reduction (product code CDH), Class I - General Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 15 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 Stanbio Laboratory devices

Submission Details

510(k) Number K800190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1980
Decision Date February 13, 1980
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDH Acid, Uric, Phosphotungstate Reduction
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 - CDH Acid, Uric, Phosphotungstate Reduction

Devices cleared under the same product code (CDH) and FDA review panel - the closest regulatory comparables to K800190.
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
K813076 · American Monitor Corp. · Nov 1981
ELVI URIC ACID-COLORIMETRIC METHOD
K792403 · Volu Sol Medical Industries · Dec 1979
ELVI URIC ACID
K792412 · Volu Sol Medical Industries · Dec 1979
SERUM, URIC ACID DETERMINATION
K790019 · Fisher Scientific Co., LLC · Feb 1979
ENZAC URIC ACID 100-TEST KIT
K772082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1977
URIC ACID TEST KIT
K770564 · Mallinckrodt Critical Care · Jun 1977