Cleared Traditional

KOVA STRIP 6 (K811219) - FDA 510(k) Clearance

Class I Microbiology device.

K811219 · Icl Scientific · Microbiology device
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May 1981
Decision
17d
Days
Class 1
Risk

K811219 is an FDA 510(k) clearance for the KOVA STRIP 6. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1645 - the FDA microbiology device 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 Icl Scientific devices

Submission Details

510(k) Number K811219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date May 21, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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 - JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)

All 37
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K904752 · Boehringer Mannheim Corp. · Apr 1991