Cleared Traditional

K972260 - CS-400 COAGULATION ANALYZER SYSTEM (A1208)

K972260 is the FDA 510(k) clearance for CS-400 COAGULATION ANALYZER SYSTEM (A1208) by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K972260 · Sigma Diagnostics, Inc. · Hematology device
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Oct 1997
Decision
125d
Days
Class 2
Risk

K972260 is an FDA 510(k) clearance for the CS-400 COAGULATION ANALYZER SYSTEM (A1208). 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 October 20, 1997 after a review of 125 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 K972260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1997
Decision Date October 20, 1997
Days to Decision 125 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
12d slower than avg
Panel avg: 113d · This submission: 125d
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 K972260.
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · Dade Behring, Inc. · Sep 1998
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
K974799 · International Technidyne Corp. · Jul 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · Boehringer Mannheim Corp. · Jan 1998
BEHRING COAGULATION SYSTEM
K970431 · Behring Diagnostics, Inc. · May 1997
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
K961908 · Helena Laboratories · Dec 1996
KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)
K960875 · Sigma Diagnostics, Inc. · Sep 1996