Cleared Traditional

K841041 - CLINI-TEK AUTO 2000 REFLECTANCE SPECTR (FDA 510(k) Clearance)

Class I Chemistry device.

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
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.