Cleared Traditional

K981555 - DIASCREEN REAGENT STRIPS

K981555 is an FDA 510(k) clearance for DIASCREEN REAGENT STRIPS, manufactured by Chronimed, Inc.. The device is a Class 1 Chemistry device with product code LJX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K981555 · Chronimed, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
31d
Days
Class 1
Risk

K981555 is an FDA 510(k) clearance for the DIASCREEN REAGENT STRIPS. Classified as Test, Urine Leukocyte (product code LJX), Class I - General Controls.

Submitted by Chronimed, Inc. (Edina, US). The FDA issued a Cleared decision on June 1, 1998 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7675 - 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 Chronimed, Inc. devices

FDA 510(k) Submission Details - K981555

510(k) Number K981555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1998
Decision Date June 01, 1998
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

LJX Device Classification - Class 1, General Controls

Product Code LJX Test, Urine Leukocyte
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.7675
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 - LJX Test, Urine Leukocyte

Devices cleared under the same product code (LJX) and FDA review panel - the closest regulatory comparables to K981555.
Healgen URS Test Strips
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K873304 · Miles Laboratories, Inc. · Sep 1987
LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
K843727 · Miles Laboratories, Inc. · Jan 1985