Cleared Traditional

K841041 - CLINI-TEK AUTO 2000 REFLECTANCE SPECTR

K841041 is the FDA 510(k) clearance for CLINI-TEK AUTO 2000 REFLECTANCE SPECTR by Miles Laboratories, Inc.. It is a Class 1 Chemistry device (product code KQO) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K841041 · Miles Laboratories, Inc. · Chemistry device
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Aug 1984
Decision
165d
Days
Class 1
Risk

K841041 is an FDA 510(k) clearance for the CLINI-TEK AUTO 2000 REFLECTANCE SPECTR. 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 August 24, 1984 after a review of 165 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K841041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date August 24, 1984
Days to Decision 165 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
77d slower than avg
Panel avg: 88d · This submission: 165d
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 K841041.
CHEMSTRIP URINE ANALYZER
K931602 · Boehringer Mannheim Corp. · Jun 1993
CLINITEK 200+ URINE CHEMISTRY ANALYZER
K926359 · Heraeus Kulzer, Inc. · Jan 1993
CHEMSTRIP URINE ANALYZER
K921087 · Boehringer Mannheim Corp. · Mar 1992
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