Cleared Traditional

K810599 - DADE RH CONTROL REAGENT

K810599 is the FDA 510(k) clearance for DADE RH CONTROL REAGENT by American Dade. It is a Class 2 Hematology device (product code KSF) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K810599 · American Dade · Hematology device
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Mar 1981
Decision
25d
Days
Class 2
Risk

K810599 is an FDA 510(k) clearance for the DADE RH CONTROL REAGENT. Classified as Kit, Quality Control For Blood Banking Reagents (product code KSF), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 25 days - a notably fast clearance cycle.

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: 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 American Dade devices

Submission Details

510(k) Number K810599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1981
Decision Date March 31, 1981
Days to Decision 25 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
88d faster than avg
Panel avg: 113d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (KSF) and FDA review panel - the closest regulatory comparables to K810599.
AVI-D CONTROL
K811713 · Ortho Diagnostic Systems, Inc. · Oct 1981
TEST CELLS
K790249 · Hyland Therapeutic Div., Travenol Laboratories · May 1979
QUALITY CONTROL SYSTEM, SPECTRA
K780097 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978
UNIVAL CONTROL CELLS
K761284 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1977