Cleared Traditional

K000528 - ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (FDA 510(k) Clearance)

Class I Hematology device.

K000528 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
50d
Days
Class 1
Risk

K000528 is an FDA 510(k) clearance for the ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on April 7, 2000 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8950 - 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K000528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date April 07, 2000
Days to Decision 50 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
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIR Reagent, Russel Viper Venom
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8950
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.