Cleared Traditional

K962864 - THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS

K962864 is an FDA 510(k) clearance for THB CAL STANDARD FOR IL CO-OXIMETERS/OX..., manufactured by Alko Diagnostic Corp.. 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.

K962864 · Alko Diagnostic Corp. · Hematology device
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Dec 1996
Decision
148d
Days
Class 2
Risk

K962864 is an FDA 510(k) clearance for the THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS. Classified as Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on December 18, 1996 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.

View all Alko Diagnostic Corp. devices

FDA 510(k) Submission Details - K962864

510(k) Number K962864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1996
Decision Date December 18, 1996
Days to Decision 148 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
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 17
Devices cleared under the same product code (KRZ) and FDA review panel - the closest regulatory comparables to K962864.
C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
K052101 · Roche Diagnostics · Aug 2005
CDS HEMATOLOGY CALIBRATOR (CDS CAL)
K041130 · Clinical Diagnostic Solutions, Inc. · Jun 2004
ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
K951071 · Alko Diagnostic Corp. · Jul 1995
CELL-DYN CALIBRATOR
K902892 · Unipath , Ltd. · Sep 1990
RAICHEM TM HEMOGLOBIN CALIBRATOR
K896921 · Reagents Applications, Inc. · Jan 1990
HGB-CAL SET/MULTIPLE
K893984 · R&D Systems, Inc. · Aug 1989