Cleared Traditional

URIC ACID/ALDH (K802371) - FDA 510(k) Clearance

Class I Chemistry device.

K802371 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
24d
Days
Class 1
Risk

K802371 is an FDA 510(k) clearance for the URIC ACID/ALDH. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 24 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

Submission Details

510(k) Number K802371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1980
Decision Date October 23, 1980
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 13
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K802371.
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
K863660 · Em Diagnostic Systems, Inc. · Oct 1986
ROCHE REAGENTS REAGENT FOR URIC ACID
K844986 · Roche Diagnostic Systems, Inc. · Jan 1985
URIC ACID 75CDO
K822884 · Technicon Instruments Corp. · Oct 1982
PRINCETON BIOMEDIX URICASE (UV)
K780859 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1978
MULTISTAT III URIC ACID TEST
K771509 · Instrumentation Laboratory CO · Sep 1977