Cleared Traditional

K960491 - MICRO HAEMATOCRIT CENTRIFUGE

K960491 is an FDA 510(k) clearance for MICRO HAEMATOCRIT CENTRIFUGE, manufactured by Hawksley & Sons , Ltd.. The device is a Class 2 Hematology device with product code CKG cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K960491 · Hawksley & Sons , Ltd. · Hematology device
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Oct 1996
Decision
260d
Days
Class 2
Risk

K960491 is an FDA 510(k) clearance for the MICRO HAEMATOCRIT CENTRIFUGE. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Hawksley & Sons , Ltd. (Lancing, West Sussex, GB). The FDA issued a Cleared decision on October 18, 1996 after a review of 260 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1025 - 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 Hawksley & Sons , Ltd. devices

FDA 510(k) Submission Details - K960491

510(k) Number K960491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1996
Decision Date October 18, 1996
Days to Decision 260 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 113d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CKG Device Classification - Class 2, Special Controls

Product Code CKG Radioimmunoassay, Acth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1025
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 - CKG Radioimmunoassay, Acth

All 20
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K960491.
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · Scantibodies Laboratory, Inc. · Jun 2002
SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT
K982608 · Sangui Biotech, Inc. · Aug 1998
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · Nichols Institute Diagnostics · Dec 1996
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996
INCSTAR ACTH IRMA
K940271 · Incstar Corp. · Aug 1994
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990