Cleared Traditional

K843695 - QCA HEMOGLOBIN KIT

K843695 is the FDA 510(k) clearance for QCA HEMOGLOBIN KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Hematology device (product code KRZ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K843695 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Dec 1984
Decision
89d
Days
Class 2
Risk

K843695 is an FDA 510(k) clearance for the QCA HEMOGLOBIN KIT. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 17, 1984 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8165 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K843695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1984
Decision Date December 17, 1984
Days to Decision 89 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
24d faster than avg
Panel avg: 113d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRZ Calibrator For Hemoglobin And Hematocrit Measurement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8165
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 - KRZ Calibrator For Hemoglobin And Hematocrit Measurement

All 14
Devices cleared under the same product code (KRZ) and FDA review panel - the closest regulatory comparables to K843695.
MSI-CAL 7
K883703 · Medical Specialties, Inc. · Nov 1988
MSI-CAL 16
K883850 · Medical Specialties, Inc. · Nov 1988
MSI-CAL 8
K883851 · Medical Specialties, Inc. · Nov 1988
DADE HEMATOLOGY CALIBRATOR PLUS
K840010 · American Dade · Apr 1984
CAL-CHEX, A HEMATOLOGY CALIBRATOR
K840261 · Streck Laboratories, Inc. · Feb 1984
CALIBRATOR 282
K831872 · Bionostics, Inc. · Jul 1983