Cleared Traditional

K854166 - HEMATOLOGY CALIBRATOR CONTROL

K854166 is an FDA 510(k) clearance for HEMATOLOGY CALIBRATOR CONTROL, manufactured by Interscience Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KRZ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K854166 · Interscience Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
148d
Days
Class 2
Risk

K854166 is an FDA 510(k) clearance for the HEMATOLOGY CALIBRATOR CONTROL. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Interscience Diagnostics, Inc. (Fairview, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 148 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K854166

510(k) Number K854166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date March 12, 1986
Days to Decision 148 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
35d slower than avg
Panel avg: 113d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRZ Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (KRZ) and FDA review panel - the closest regulatory comparables to K854166.
HEMOCUE HEMOGLOBIN CALIBRATOR
K882600 · React and Co. · Jul 1988
REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801
K873832 · In Vitro Diagnostics, Inc. · Nov 1987
CYANMETHEMOGLOBIN STANDARD
K871283 · U. S. Diagnostics, Inc. · Apr 1987
LIQUI-HEME HEMOGLOBIN CALIBRATORS
K842668 · Biodiagnostic Intl · Mar 1985
QCA HEMOGLOBIN KIT
K843695 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
DADE HEMATOLOGY CALIBRATOR PLUS
K840010 · American Dade · Apr 1984
K854166 · HEMATOLOGY CALIBRATOR CONTROL
Download PDF Interscience Diagnost…