Cleared Traditional

K021162 - AMAX DENSITY COAGULATION ANALYZER

K021162 is the FDA 510(k) clearance for AMAX DENSITY COAGULATION ANALYZER by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K021162 · Sigma Diagnostics, Inc. · Hematology device
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Aug 2002
Decision
141d
Days
Class 2
Risk

K021162 is an FDA 510(k) clearance for the AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMA.... Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 30, 2002 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K021162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2002
Decision Date August 30, 2002
Days to Decision 141 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
28d slower than avg
Panel avg: 113d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K021162.
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · Instrumentation Laboratory CO · Mar 2004
HEMOCHRON RESPONSE/SYSTEM
K030818 · International Technidyne Corp. · Apr 2003
MODIFICATION TO STANDARD HUMAN PLASMA
K023141 · Dade Behring, Inc. · Jan 2003
HEMOCHRON JR. SIGNATURE +
K020798 · International Technidyne Corp. · Mar 2002
BCS SYSTEM
K013114 · Dade Behring, Inc. · Nov 2001
BCT SYSTEM
K011665 · Dade Behring, Inc. · Aug 2001