Cleared Traditional

K840829 - KYOTEST UGK

K840829 is the FDA 510(k) clearance for KYOTEST UGK by Kyoto Diagnostics, Inc.. It is a Class 2 Hematology device (product code JIL) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K840829 · Kyoto Diagnostics, Inc. · Hematology device
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Apr 1984
Decision
55d
Days
Class 2
Risk

K840829 is an FDA 510(k) clearance for the KYOTEST UGK. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Kyoto Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 55 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K840829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date April 19, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 113d · This submission: 55d
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 Hematology 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 K840829.
UROPAPER EIKEN GK
K843758 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN HAG
K843759 · Syn-Kit, Inc. · Dec 1984
UROPAPER EIKEN G
K843760 · Syn-Kit, Inc. · Dec 1984
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600 · Miles Laboratories, Inc. · Sep 1983
BIOSTRIP G
K820594 · Helena Laboratories · May 1982
UROPAPER EIKEN UHAG
K811816 · Syn-Kit, Inc. · Dec 1981