Cleared Traditional

K940840 - ACT CONTROL SET

K940840 is the FDA 510(k) clearance for ACT CONTROL SET by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K940840 · Sigma Diagnostics, Inc. · Hematology device
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Jul 1994
Decision
146d
Days
Class 2
Risk

K940840 is an FDA 510(k) clearance for the ACT CONTROL SET. 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 July 19, 1994 after a review of 146 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 K940840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1994
Decision Date July 19, 1994
Days to Decision 146 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
33d slower than avg
Panel avg: 113d · This submission: 146d
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 K940840.
CASCASE 480 SNSLYZER
K951497 · Helena Laboratories · Sep 1995
BEHRING FIBRINTIMER A
K926551 · Behring Diagnostics, Inc. · Apr 1995
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · International Technidyne Corp. · Oct 1994
JR. MICROCOAGULATION SYSTEM
K940401 · International Technidyne Corp. · May 1994
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
K934747 · R & D Batteries, Inc. · Dec 1993
DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI
K933188 · Baxter Diagnostics, Inc. · Sep 1993