Cleared Traditional

K902892 - CELL-DYN CALIBRATOR

K902892 is an FDA 510(k) clearance for CELL-DYN CALIBRATOR, manufactured by Unipath , Ltd.. The device is a Class 2 Hematology device with product code KRZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K902892 · Unipath , Ltd. · Hematology device
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Sep 1990
Decision
70d
Days
Class 2
Risk

K902892 is an FDA 510(k) clearance for the CELL-DYN CALIBRATOR. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Unipath , Ltd. (Mountain View, US). The FDA issued a Cleared decision on September 10, 1990 after a review of 70 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 Unipath , Ltd. devices

FDA 510(k) Submission Details - K902892

510(k) Number K902892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1990
Decision Date September 10, 1990
Days to Decision 70 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
43d faster than avg
Panel avg: 113d · This submission: 70d
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 17
Devices cleared under the same product code (KRZ) and FDA review panel - the closest regulatory comparables to K902892.
CDS HEMATOLOGY CALIBRATOR (CDS CAL)
K041130 · Clinical Diagnostic Solutions, Inc. · Jun 2004
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
K962864 · Alko Diagnostic Corp. · Dec 1996
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
K951071 · Alko Diagnostic Corp. · Jul 1995
RAICHEM TM HEMOGLOBIN CALIBRATOR
K896921 · Reagents Applications, Inc. · Jan 1990
HGB-CAL SET/MULTIPLE
K893984 · R&D Systems, Inc. · Aug 1989
MSI-CAL 7
K883703 · Medical Specialties, Inc. · Nov 1988