Cleared Traditional

K821738 - CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST

K821738 is the FDA 510(k) clearance for CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST by Miles Laboratories, Inc.. It is a Class 1 Chemistry device (product code KQO) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821738 · Miles Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
22d
Days
Class 1
Risk

K821738 is an FDA 510(k) clearance for the CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982 after a review of 22 days - a notably fast clearance 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: 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K821738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1982
Decision Date July 06, 1982
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 21
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K821738.
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · Miles Laboratories, Inc. · Jul 1984
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · Miles Laboratories, Inc. · Mar 1977
INSTRUMENTED SYSTEM FOR URINALYSIS
K760472 · Miles Laboratories, Inc. · Oct 1976