Cleared Traditional

K811713 - AVI-D CONTROL

K811713 is an FDA 510(k) clearance for AVI-D CONTROL, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code KSF cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K811713 · Ortho Diagnostic Systems, Inc. · Hematology device
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Oct 1981
Decision
128d
Days
Class 2
Risk

K811713 is an FDA 510(k) clearance for the AVI-D CONTROL. Classified as Kit, Quality Control For Blood Banking Reagents (product code KSF), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on October 23, 1981 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K811713

510(k) Number K811713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1981
Decision Date October 23, 1981
Days to Decision 128 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 113d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSF Device Classification - Class 2, Special Controls

Product Code KSF Kit, Quality Control For Blood Banking Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9650
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 - KSF Kit, Quality Control For Blood Banking Reagents

All 8
Devices cleared under the same product code (KSF) and FDA review panel - the closest regulatory comparables to K811713.
DADE RH CONTROL REAGENT
K810599 · American Dade · Mar 1981
RST-SERIES CONTROL
K800658 · Gamma Biologicals, Inc. · Apr 1980
ORTHO ANTISERA CONTROL
K800310 · Ortho Diagnostics, Inc. · Mar 1980
TEST CELLS
K790249 · Hyland Therapeutic Div., Travenol Laboratories · May 1979
COUNTER CHECK, H001, H002, H003
K790025 · Diagnostic Technology, Inc. · Jan 1979
QUALITY CONTROL SYSTEM, SPECTRA
K780097 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978