Cleared Traditional

K861733 - ADDITIONAL KYOTEST URINE TEST REAGENT S...

K861733 is the FDA 510(k) clearance for ADDITIONAL KYOTEST URINE TEST REAGENT S... by Kyoto Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIL) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K861733 · Kyoto Diagnostics, Inc. · Chemistry device
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Jul 1986
Decision
80d
Days
Class 2
Risk

K861733 is an FDA 510(k) clearance for the ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Kyoto Diagnostics, Inc. (Elkhart, US). The FDA issued a Cleared decision on July 25, 1986 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 Kyoto Diagnostics, Inc. devices

Submission Details

510(k) Number K861733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date July 25, 1986
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 38
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K861733.
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500 · American Diagnostic Corp. · Mar 1987
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255 · Behring Diagnostics, Inc. · Oct 1986
BIOTEL (TM)/ DIABETES
K855239 · American Diagnostic Corp. · Jun 1986
UROPAPER EIKEN GP
K843753 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN 7
K843754 · Syn-Kit, Inc. · Dec 1984