Cleared Traditional

K841041 - CLINI-TEK AUTO 2000 REFLECTANCE SPECTR

K841041 is an FDA 510(k) clearance for CLINI-TEK AUTO 2000 REFLECTANCE SPECTR, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K841041

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.

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 31
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