Cleared Traditional

K972260 - CS-400 COAGULATION ANALYZER SYSTEM (A1208)

K972260 is an FDA 510(k) clearance for CS-400 COAGULATION ANALYZER SYSTEM (A1208), 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 125-day FDA review.

K972260 · Sigma Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K972260

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.

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 K972260.
HEPTRAC ELECTRONIC QUALITY CONTROL
K981815 · Medtronic Blood Management · Jul 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
SYSMEX CA-1000/SYSMEX CA-5000
K964946 · Sysmex Corp. · Mar 1997
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
K961908 · Helena Laboratories · Dec 1996