Cleared Traditional

DIASCREEN REAGENT STRIPS (K971976) - FDA 510(k) Clearance

Class I Hematology device.

K971976 · Dia-Screen Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Jun 1997
Decision
19d
Days
Class 1
Risk

K971976 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 Dia-Screen Corp. (Edina, US). The FDA issued a Cleared decision on June 17, 1997 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7675 - 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 Dia-Screen Corp. devices

Submission Details

510(k) Number K971976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date June 17, 1997
Days to Decision 19 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 113d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.