Cleared Traditional

K813056 - AUTOMATED URINALYSIS SYSTEM

K813056 is an FDA 510(k) clearance for AUTOMATED URINALYSIS SYSTEM, manufactured by Kyoto Daiichi Kagaku Co., Ltd.. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K813056 · Kyoto Daiichi Kagaku Co., Ltd. · Chemistry device
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May 1982
Decision
188d
Days
Class 1
Risk

K813056 is an FDA 510(k) clearance for the AUTOMATED URINALYSIS SYSTEM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Kyoto Daiichi Kagaku Co., Ltd. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 188 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Kyoto Daiichi Kagaku Co., Ltd. devices

FDA 510(k) Submission Details - K813056

510(k) Number K813056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1981
Decision Date May 05, 1982
Days to Decision 188 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 88d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

KQO Device Classification - Class 1, General Controls

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
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 - KQO Automated Urinalysis System

All 34
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K813056.
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · Miles Laboratories, Inc. · Jul 1984
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738 · Miles Laboratories, Inc. · Jul 1982
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · Miles Laboratories, Inc. · Mar 1977
INSTRUMENTED SYSTEM FOR URINALYSIS
K760472 · Miles Laboratories, Inc. · Oct 1976