Cleared Traditional

K021162 - AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED

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

K021162 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K021162

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.

JPA Device Classification - Class 2, Special Controls

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 158
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