Cleared Traditional

K000527 - ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094

K000527 is an FDA 510(k) clearance for ACCUCLOT DRVVT SCREEN, manufactured by Sigma Diagnostics, Inc.. The device is a Class 1 Hematology device with product code GIR cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K000527 · 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

K000527 is an FDA 510(k) clearance for the ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094. 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

FDA 510(k) Submission Details - K000527

510(k) Number K000527 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

GIR Device Classification - Class 1, General Controls

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.

Regulatory Peers - GIR Reagent, Russel Viper Venom

All 9
Devices cleared under the same product code (GIR) and FDA review panel - the closest regulatory comparables to K000527.
REAGENT, RUSSEL VIPER VENOM - LA SCREEN
K132130 · Dsrv, Inc. · Jan 2014
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
K110031 · Instrumentation Laboratory CO · Aug 2011
STA - STACLOT DRVV SCREEN
K061805 · Diagnostica Stago, Inc. · Dec 2006
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528 · Sigma Diagnostics, Inc. · Apr 2000
CRYOCHECK LA SURE, MODEL SUR25-10
K990580 · Precision Biologic · Jul 1999
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
K990579 · Precision Biologic · Jul 1999